New York Dental CBCT Rule: Part 16 Explained

New York has made cone beam CT a separately regulated modality for the first time, and dental practices are the largest group affected. The Department of Health repealed and replaced 10 NYCRR Part 16 in its entirety effective July 22, 2026. The new Part contains section 16.65, Diagnostic Cone Beam Computed Tomography (CBCT), which imposes equipment requirements, a written quality assurance program, acceptance and annual testing by a licensed medical physicist, patient dose documentation, and — by January 22, 2028 — accreditation by a nationally recognized program.¹²

For a decade, a dental CBCT in New York was regulated much like any other dental x-ray unit. That is no longer true. The Department said so plainly in its response to public comment: the same cone beam CT model used in a medical practice already required accreditation and a quality assurance program, while the identical unit in a dental practice did not, and the update "now provides a degree of equity for patient care and safety."¹

This guide walks through what section 16.65 actually requires, which practices it reaches, what changes for the rest of the office, what the Department estimates it costs, and the open questions a practice should resolve before its next inspection. DRPS provides medical physicist consulting and equipment performance evaluation across our service locations, including New York.

Introduction

Two things happened on July 22, 2026, and the second one is the one practices miss.

The first is straightforward: a new section of the state radiation code now addresses cone beam CT directly. Section 16.65 defines CBCT as "a medical imaging technique consisting of x-ray computed tomography where the x-rays are divergent, forming a cone," and section 16.53(c)(3) — the dental radiographic installations section — routes dental CBCT into it.²

The second is structural. Adding a CBCT to a dental office changes the regulatory character of the whole office, because section 16.23(a)(1) writes its quality assurance obligation around the modalities a facility operates, not around the specialty on the door. That is covered below and it is the single most under-appreciated consequence of the new Part.

A note on scope before going further. This article addresses practices in New York State outside the five boroughs of New York City. Radiation in New York City is regulated under the New York City Health Code, Article 175, which has its own — and in places quite different — dental CBCT regime. The two are compared in the Regulatory Considerations section.

Topic Explanation

What was adopted, and when

The rulemaking is recorded as Notice of Adoption I.D. No. HLT-40-25-00001-A, Filing No. 646, filed July 7, 2026, effective July 22, 2026, adopted under Public Health Law section 225. The action was a repeal of Part 16 and the addition of a new Part 16 — not an amendment. Every citation to the old Part is now a citation to a superseded rule.¹

The Department received approximately 154 written comments. The New York State Dental Association and the New York State Society of Oral and Maxillofacial Surgeons both argued that accreditation for dental cone beam CT was excessive and burdensome for small practices, and that accrediting bodies would not be able to accredit dental facilities. The Department rejected both points, stating that it had contacted the Intersocietal Accreditation Commission and determined the concerns were unfounded.¹

What section 16.65 requires

The section is organized into five subdivisions. As published in the rulemaking record, they read as follows.

(a) Equipment. Seven requirements: diagnostic-type protective tube housing; activation controls in a protected area positioned so the operator must remain there for the entire exposure; visual signals at both the control panel and the system showing when x-rays are being produced and terminated; a control allowing the operator to terminate an exposure at any time during a scan or series; a clearly and conspicuously labeled emergency shutoff; reset of the conditions of operation after a premature termination before another scan may begin; and means for the operator to maintain view of the patient by window or mirror together with two-way aural communication.²

(b) Quality assurance program. A written program identifying the facility's New York State registration identification number, the make and model of the unit, the staff trained to perform QC testing and patient care, and the licensed medical physicist; holding the most recent physicist survey, with copies retained three years; documenting preventive maintenance and service records including corrective actions; and establishing a formalized in-service training program delivered before patient use and annually thereafter, covering basic radiation principles and safety, machine-model-specific training, and the displays and systems used for viewing. Training documentation is retained three years, and the practitioner must attest in writing to each qualified employee's completion of initial and annual training. Section 16.65(b)(7)(vi) requires that examinations be performed only when clinically indicated and by written order of the practitioner; (b)(7)(vii) prohibits imaging any person for the express purpose of testing or demonstrating the equipment.²

(c) Quality control program. Subdivision (c)(1) builds the QC program on the manufacturer's requirements, or — where the manufacturer supplies none — on a program developed in consultation with the licensed medical physicist, using a manufacturer phantom capable of completing the tests. Subdivision (c)(2) assigns the physicist testing. Subdivision (c)(3) assigns the registrant its own recurring duties. Subdivision (c)(4) requires written calibration procedures kept on the premises.²

(d) Additional requirements. Each patient record must document exposure, dose area product, or air kerma. The most common exam technique and resulting dose for pediatric and adult patients, as determined annually by the licensed medical physicist, must be displayed at the operator console. The system may be operated only by an individual specifically trained in its operation.²

(e) Exemptions. CBCT used exclusively for non-diagnostic purposes is exempted from the accreditation requirement — the examples given are attenuation correction, biopsy, guiding or delivering treatment planning, and post-operative units.²

Who does the testing

As published, section 16.65(c)(2) assigns initial acceptance testing and annual quality control testing to a New York State licensed medical physicist, consistent with currently accepted professional standards. In its Assessment of Public Comment the Department stated that it "did amend the regulation to clarify that certain testing can be performed by a 'licensed medical physicist or other individual authorized by law or regulation.'"¹

That distinction matters in New York because medical physics is a licensed profession under Article 166 of the Education Law, and licensure is granted per specialty. A physicist licensed only in therapeutic radiological physics does not hold the diagnostic radiological physics license this work sits under, and practising the profession in New York requires a New York license in the applicable specialty.⁸

Key Technical Principles

The physicist test list

Testing is required at initial acceptance, after any major repair, software upgrade, or change to any part of the system affecting unit output or patient dose, and annually thereafter. The tests enumerated in the published rulemaking record are:²

One clause that appeared in the published proposal is not in the adopted rule. Proposed clause 16.65(c)(2)(i)(l) would have required documentation of area exposure results from an NVLAP approved laboratory at the console or operator location for a duration of one year. The Department removed it, explaining that the requirement was determined "not to be protective of public health when compared with the burden of compliance."¹ A practice reading a summary written before adoption may still see that requirement listed; it is not in force.

A scheduling detail worth getting right

The 24-month calibration interval on the dosimetry system and the 12-month interval between surveys do not line up on their own. Consider a chamber whose ADCL calibration is dated March 2026, and annual surveys performed each September:

[ \text{Survey 1 (Sept 2026): chamber age} = 6 \text{ months} \quad \checkmark ] [ \text{Survey 2 (Sept 2027): chamber age} = 18 \text{ months} \quad \checkmark ] [ \text{Survey 3 (Sept 2028): chamber age} = 30 \text{ months} \quad \times ]

One calibration covers two annual surveys, but only if the second falls inside the 24-month window. A chamber calibrated in March covers September surveys in 2026 and 2027 and must be recalibrated before the 2028 visit. Practices that engage a physicist should expect the physicist to manage this; practices that rotate vendors on price should ask to see the calibration certificate and its date, because an out-of-window chamber invalidates the output calibration the rest of the survey rests on.

What the registrant does between visits

Section 16.65(c)(3) places recurring duties on the facility itself, not on the physicist:²

• Daily, or on each day of CBCT patient imaging: equipment function indicators and mechanical and other safety checks; film processing or digital system QC where applicable; CT number for water and bone; field uniformity; artifacts; and monitoring of repeat or rejected patient images including the reason for each.
• Weekly: image viewing system software and hardware, as applicable.
• Ongoing: repeat and reject analysis as determined by section 16.23(a)(1)(xi).

A practice that treats the annual physicist visit as the whole of its obligation is not compliant. The daily list is short but it is a daily list, and the repeat/reject analysis is a program, not a form.

For the underlying test methodology behind most of these measurements, see our guide to dental CBCT quality control under AAPM TG-261 and the companion discussion of cone beam CT dose.

Clinical Impact

The consequence most practices have not priced is that a CBCT pulls the entire office into section 16.23(a)(1).

That subdivision applies to "each radiation facility conducting diagnostic x-ray, fluoroscopy, cone beam CT, CT and/or radioactive materials procedures," and it excepts "intraoral dental, panoramic dental, podiatric x-ray, and veterinary facilities."² A dental office running only intraoral units and a panoramic sits comfortably inside that exception. Once it operates a cone beam CT, the exception no longer describes the facility, and the full diagnostic-facility quality assurance program attaches: a written QA manual of policies and procedures, quality control tests with correction of deficiencies, equipment records, a formalized in-service training program, entrance skin exposure measurement for common examinations, provision of that dose information to any patient who asks, repeat and reject analysis, and — under 16.23(a)(1)(xii) — written policies ensuring continuity of care for electronically stored images, with at least annual testing of that system.

That is a genuine program, and it is the part of the new Part most likely to be discovered during an inspection rather than in advance.

Three further obligations sit alongside section 16.65:

• Acceptance testing before first human use. Section 16.5(h) requires acceptance testing of medical and chiropractic diagnostic equipment and associated software before first use on humans, performed by an individual competent to perform such testing and approved by a licensed medical physicist, repeated after reassembly or major upgrade.²
• Annual program review. Section 16.5(i) requires the registrant to conduct, or cause to be conducted, an annual review of the radiation protection program's content and implementation.²
• Registration timing. Section 16.50 requires the registration application 30 to 60 days prior to a new installation, a renewal, or any change in ownership, operating status, or location, with changes reported in writing within 10 days.²

Practical Optimization Tips

1. Confirm the unit is actually a cone beam CT

Several widely installed dental product families include both 2D panoramic-only models and 3D cone beam models under nearly identical names. If the unit is a 2D panoramic system, section 16.65 does not apply to it at all and the office remains within the 16.23(a)(1) exception. Read the full model designation off the label — not the family name — before committing to a compliance path or a service contract.

2. Put the console dose posting on the annual survey deliverable list

Section 16.65(d)(2) requires the pediatric and adult most-common-technique doses, as determined annually by the physicist, to be displayed at the operator console. This is a physical posting the inspector can look for, and it is easy to leave in the report instead of on the wall. Ask the physicist to supply it in a postable format.

3. Build the daily QC sheet before the first patient

The (c)(3) daily list includes CT number for water and bone and field uniformity — measurements that need a phantom and a defined procedure. Those procedures come from the manufacturer's QC program or, absent one, from the program developed in consultation with the physicist under (c)(1). Establish them at acceptance, not at the first inspection.

4. Start accreditation early, and treat 90 days as real

For a practice operating on July 22, 2026, accreditation is due January 22, 2028. For a practice opening after the effective date, the rule requires demonstrating that the accreditation process has been initiated within 90 days of the start of operations, with completion inside 18 months. Loss of accreditation, or failure to obtain it, must be reported to the Department within 30 days.²

5. Get the operator question answered in writing

Section 16.65(d)(3) requires a specifically trained operator, and section 16.19 separately governs who may position patients, set techniques, and apply radiation. Section 16.19(a)(1) addresses dental assistants operating "dental radiographic equipment for dental x-ray procedures" under a dentist's supervision, per 10 NYCRR 89.30 and Public Health Law section 3516.² Whether a cone beam CT is within that authority is not resolved on the face of the text. Ask the Bureau of Environmental Radiation Protection and keep the answer.

Common pitfalls to avoid

• Assuming the annual physicist visit is the whole program. The (c)(3) daily and weekly duties belong to the registrant.
• Budgeting for the CBCT and forgetting the office. Section 16.23(a)(1) now reaches the whole facility.
• Citing a pre-adoption summary. The NVLAP area-exposure clause was removed at adoption; several summaries written during the comment period still list it.
• Treating New York City as the same jurisdiction. It is not. See below.
• Assuming a therapy physics license covers the work. Article 166 licensure is per specialty.

Regulatory Considerations

New York City is a different rulebook

Inside the five boroughs, radiation is regulated under the New York City Health Code, Article 175, administered by the NYC Department of Health and Mental Hygiene, Office of Radiological Health. Article 175 routes dental CBCT away from its general CT section: section 175.08 defines a "CT x-ray system" to include "CBCT systems that are used for other than dental x-ray scans," and section 175.55 applies "[e]xcept for dental registrants possessing cone beam computed tomography." Dental CBCT therefore runs through sections 175.40 and 175.49(r).³

The practical differences are substantial:

Two items on that table deserve emphasis. New York City requires semi-annual quality assurance tests for image noise, image uniformity, reconstructed image measurement accuracy, and high contrast spatial resolution, in addition to the annual testing — so a city practice is on a two-visit-per-year cadence.³ And because sections 175.46(b) and (h) exempt "dental (except CBCT)" installations from the full operator's booth requirements, a New York City dental CBCT owes the complete booth under 175.46(d) through (g), including permanently fixed barriers at least seven feet high.³

One caution worth stating plainly. The practitioner press and the accrediting community have reported that the new state CBCT rule does not reach New York City. Part 16 itself, however, contains no express New York City exclusion inside section 16.65. The Part does carve out large health districts where the Department intends to — sections 16.1(b)(2) and 16.110 both address districts of more than 2,000,000 people, but only for radioactive-materials licensure and its fees, and section 16.70(a) excludes cities of two million or more from the body-scanning section. None of those carve-outs reaches the radiation-equipment provisions that contain section 16.65. The coordination between the two programs runs through registration, fee, and inspection provisions at sections 16.50(j), 16.40(b)(2), and 16.10(a)(1).² A New York City practice should confirm its accreditation position with the state Bureau of Environmental Radiation Protection rather than rely on the city exemption alone.

Two open questions in the text

Medical event reporting. Section 16.25(a)(9) through (11) make a medical event out of a CT scan performed on the wrong person, performed on the wrong body part, or resulting in organ damage, hair loss, or erythema as determined by a physician.² The text says "CT scan," not "CT or CBCT" — unlike the New York City Health Code, which names both explicitly.³ Because section 16.59(a)(1) defines a CT scan as an imaging procedure using x-rays to create cross-sectional images of the human body, a CBCT event is probably captured, but the drafting is not explicit.

Operator credentialing. Section 16.59(f)(1) requires that a CT system be operated only by a physician or a radiologic technologist licensed under Article 35 of the Public Health Law. Section 16.65 contains no equivalent clause — only "specifically trained."² The difference is deliberate enough to notice and ambiguous enough to verify.

A note on sourcing

The Notice of Adoption records that non-substantial changes were made at adoption to sections 16.65(c)(2), (c)(2)(i), (c)(2)(i)(l) and (e), among others.¹ The subdivision-level descriptions in this article follow the express terms as published in the rulemaking record, together with the amendments the Department described in its Assessment of Public Comment. Before relying on the precise wording of those subdivisions, obtain the filed text from the Department's Bureau of Program Counsel.

Inspections and fees

Registered installations are inspected periodically by the Department, by a certified county or part-county health officer, or by a Certified Radiation Equipment Safety Officer (CRESO) — a certification issued by the Department under section 16.10(d); per the Department's registration FAQ, CRESOs inspect dental, podiatric, and veterinary facilities. Under the new Part the inspection frequency is set administratively by the Department rather than fixed in the rule, and initial inspections should occur within the first year of operations.²⁹

Dental, podiatric, bone densitometry, and veterinary installations are fee Category VI. The Regulatory Impact Statement published with the rule shows that category rising from $65 to $100, part of an average 68% fee increase — the first since 2001.²

Key Takeaways

• New 10 NYCRR Part 16 took effect July 22, 2026; section 16.65 regulates cone beam CT as its own modality for the first time.
• Everything except accreditation applied immediately: equipment features, written QA program, in-service training with written practitioner attestation, acceptance and annual physicist testing, registrant daily and weekly QC, console dose posting, and per-patient dose documentation.
• Accreditation is due January 22, 2028 for practices operating on the effective date; new practices must initiate within 90 days and complete within 18 months.
• Testing falls to a New York State licensed medical physicist; Article 166 licensure is granted per specialty.
• Adding a CBCT moves the whole dental office out of the intraoral/panoramic exception in section 16.23(a)(1).
• New York City is a separate regime with no dental CBCT accreditation requirement, semi-annual image-quality testing, five-year record retention, and a full operator's booth.

Frequently Asked Questions (FAQs)

When did New York's new dental CBCT rule take effect?

The Department repealed and replaced 10 NYCRR Part 16 by Notice of Adoption I.D. No. HLT-40-25-00001-A, Filing No. 646, filed July 7, 2026, effective July 22, 2026. Every requirement of section 16.65 other than accreditation applied from that date.

Does the rule apply to dental practices in New York City?

Practices inside the five boroughs are regulated under NYC Health Code Article 175. The practitioner press and the accrediting community report that the new state CBCT requirements do not reach New York City. Part 16 contains no express city exclusion within section 16.65, so a city practice should confirm its position with the state Bureau of Environmental Radiation Protection rather than rely on the city exemption alone.

What is the accreditation deadline?

January 22, 2028 for a practice operating on the July 22, 2026 effective date — eighteen months after the effective date of the Part. A practice beginning operations later has eighteen months to complete accreditation and must demonstrate it initiated the process within 90 days of starting.

Who is allowed to perform the testing?

As published, section 16.65(c)(2) assigns acceptance and annual testing to a New York State licensed medical physicist. In adopting the rule the Department stated it amended the regulation to clarify that certain testing can be performed by a licensed medical physicist or other individual authorized by law or regulation.

Does adding a CBCT change anything for the rest of the practice?

Yes. Section 16.23(a)(1) reaches facilities conducting cone beam CT and excepts only intraoral dental, panoramic dental, podiatric, and veterinary facilities. Once the office operates a CBCT, the exception no longer describes it and the full diagnostic-facility quality assurance program applies.

Do dental assistants still operate the CBCT?

Section 16.65(d)(3) requires a specifically trained operator, on top of section 16.19, which governs who may position patients, set techniques, and apply radiation. Section 16.19(a)(1) addresses dental assistants operating dental radiographic equipment for dental x-ray procedures under a dentist's supervision. Whether that reaches a cone beam CT is not answered on the face of the text.

What does compliance cost?

In its Regulatory Impact Statement the Department estimated accreditation at about $3,000 for a three-year period and cone beam CT quality assurance testing at approximately $800 to $1,200 per year, and raised the Category VI annual registration fee from $65 to $100. These are the Department's estimates, not market prices.

Conclusion

The substance of section 16.65 is not exotic. Most of what it requires — output calibration against a traceable standard, contrast and noise measurements, artifact evaluation, a written QA program, trained operators — is what a competent dental CBCT program should already have been doing under AAPM TG-261. What changed is that New York now requires it, names a licensed professional to do part of it, sets a date for accreditation, and inspects against it.

The practices most exposed are not the ones with poor physics. They are the ones that bought a cone beam CT as an upgrade to a panoramic unit and never revisited the compliance category that purchase moved them into. The first useful step is small: confirm the model, read section 16.65 against what the office actually does today, and find the gaps while there is still time before January 22, 2028.

How DRPS Can Help

Diagnostic Radiation Physics Services performs equipment performance evaluations and radiation protection surveys for dental practices, and supports facilities through accreditation. DRPS provides medical physicist consulting and radiation safety officer services delivered by board-certified medical physicists, across our service locations including New York.

For a New York dental practice, the practical package is an acceptance or annual evaluation under section 16.65, the written quality assurance and quality control program the section requires, the console dose values in a postable form, and the daily and weekly QC procedures the registrant will run between visits.

Related Resources

• Dental CBCT quality control under AAPM TG-261
• Cone beam CT dose
• Dental intraoral and panoramic radiography QC
• ACR accreditation physics requirements
• Repeat and reject analysis
• Medical physicist consulting

References

1. New York State Department of State. New York State Register, July 22, 2026 — Department of Health Notice of Adoption, Ionizing Radiation, I.D. No. HLT-40-25-00001-A, Filing No. 646, with Assessment of Public Comment. dos.ny.gov
2. New York State Department of Health. Express terms, 10 NYCRR Part 16 (Ionizing Radiation), I.D. No. HLT-40-25-00001-P. regs.health.ny.gov
3. New York City Department of Health and Mental Hygiene. New York City Health Code, Article 175: Radiation Control. nyc.gov
4. New York City Department of Health and Mental Hygiene. Applying for a Radiation Producing Equipment Permit (x-ray). nyc.gov
5. Intersocietal Accreditation Commission. IAC Dental CT Accreditation Program. intersocietal.org
6. New York State Society of Oral and Maxillofacial Surgeons. New York State Adopts New CBCT Regulations: What Dental Practices Need to Know. August 10, 2026. nyssoms.org
7. New York State Dental Journal. Department of Health Exerts Strong Control over CBCT in Dental Offices. Vol. 92, Iss. 5. commons.ada.org
8. New York State Education Department, Office of the Professions. Medical Physics License Requirements. op.nysed.gov
9. New York State Department of Health. Radiation Equipment Registration: Frequently Asked Questions. health.ny.gov
10. American Association of Physicists in Medicine. AAPM Task Group Report No. 261: Comprehensive quality control methodology and management of dental and maxillofacial cone beam computed tomography (CBCT) systems. 2024. aapm.org