New York State Adopts New CBCT Regulations: What Dental Practices Need to Know

The new regulations include an entirely new Section 16.65, which specifically regulates CBCT installations in dental offices.

These requirements are substantial and technical and will require assistance from a New York State licensed medical physicist to help ensure compliance.

Important Compliance Timeline

Effective July 22, 2026:The provisions of Section 16.65 that are not related to the accreditation requirement are effective immediately, including:

  • Specific CBCT equipment requirements
  • A Quality Assurance (QA) program
  • A Quality Control (QC) program
  • Annual quality control testing
  • Documentation of patient radiation exposure doses
  • Ensuring only qualified personnel operate CBCT equipment

By January 22, 2028:
Dental practices using CBCT equipment for diagnostic purposes must obtain accreditation through a nationally recognized accreditation program acceptable to NYSDOH.

New CBCT Users After July 22, 2026:
Dental practices that begin using CBCT equipment after July 22, 2026, also have 18 months to achieve accreditation, but must initiate the accreditation application within 90 days of beginning CBCT use.

    Personnel Authorized to Operate CBCT Equipment

    New York currently allows:

    • Unlicensed dental assistants to take CBCT scans after completing training provided by the CBCT manufacturer
    • Registered dental assistants to take CBCT scans
    • Dental hygienists to take CBCT scans

    The new regulations do not change these requirements.

    All employees taking CBCT scans must complete annual in-service training as part of the required Quality Assurance Program.

    Annual training must include:

    1. Basic radiation principles and safety;
    2. Machine model-specific training;
    3. Displays and systems used for viewing;
    4. Documentation of initial and annual training completion maintained for three years and available upon request;
    5. Written practitioner attestation confirming employee completion of initial and annual training for each qualified employee allowed to operate CBCT equipment;
    6. Examinations performed only when clinically indicated and by written order of the practitioner;
    7. No person regularly employed for imaging training demonstrations. No person may be imaged solely for the purpose of testing or demonstrating equipment.

    Quality Assurance Program Requirements

    The Quality Assurance Program must include:

    1. Identification of the facility New York State registration identification number;
    2. Identification of the make and model of the unit;
    3. Identification of staff trained to perform quality control testing and patient care;
    4. Identification of the licensed medical physicist;
    5. The most recent licensed medical physicist survey;
    6. Copies of licensed medical physicist surveys maintained electronically or on paper for three years;
    7. Documentation of preventive maintenance and service records, including corrective actions.

    CBCT Equipment Requirements

    CBCT systems must meet the following requirements:

    1. Protective housing shall be of diagnostic type;
    2. X-ray activation controls shall be mounted in a protected area and situated so the operator remains in the protected area during the entire exposure;
    3. Control panels and CBCT systems must include visual signals indicating when x-rays are being produced and when production has terminated;
    4. CBCT systems must include a control allowing the operator to terminate x-ray exposure at any time during a scan or series of scans;
    5. CBCT systems must include a clearly labeled emergency shutoff button or switch;
    6. Premature termination of x-ray exposure requires resetting of CBCT operating conditions before another scan or series of scans;
    7. CBCT systems must allow the operator to maintain patient visibility through a window or mirror and provide two-way aural communication.

    Quality Control Testing Requirements

    Quality Control testing must be performed annually as part of a Quality Control Program.

    Each CBCT unit must be tested according to:

    • The manufacturer’s requirements; or
    • A quality control test program developed in consultation with a New York State licensed medical physicist if one is not provided by the manufacturer.

    The Quality Control testing program must include:

    1. A phantom test device from the manufacturer capable of completing Quality Assurance/Quality Control testing as directed by the manufacturer or licensed medical physicist;
    2. Documentation of Quality Control test results and completion, including any system used for image viewing.

    Licensed Medical Physicist Testing Requirements

    A licensed medical physicist or other legally authorized person is required to perform Quality Control testing involving technical measurements, including:

    1. Initial acceptance testing, testing after major repair, software upgrades, or changes affecting unit output and patient dose, and annual testing thereafter;
    2. Calibration of the CBCT unit using a calibrated dosimetry system traceable to the National Institute of Standards and Technology (NIST);
    3. Dose area product (DAP) or kerma area product (KAP);
    4. Dose to pediatric and adult patients for the most common exam techniques;
    5. CT number for water or other reference material;
    6. Low and high contrast resolution;
    7. Noise;
    8. Scan localization accuracy;
    9. Artifacts;
    10. Field of View;
    11. Scatter measurements performed within 30 days of installation.

    Additional Dentist Responsibilities for Quality Control

    Dentists registering a CBCT installation are responsible for additional Quality Control requirements, including daily, weekly, and ongoing responsibilities.

    Daily (or days of CBCT patient imaging)

    • Equipment function indicators, mechanical, and other safety checks;
    • Film processing or digital system Quality Control, if applicable;
    • CT number for water and bone;
    • Field uniformity;
    • Artifacts;
    • Monitoring repeat or rejected patient images, including reasons for repeat or rejection.

    Weekly

    • Image viewing system software and hardware, as applicable.

    Ongoing

    • Repeat/reject analysis designed to identify and correct problems and optimize quality;
    • Maintaining written procedures for appropriate calibration of the CBCT x-ray system and making them available for review by NYSDOH at the radiation installation where the CBCT system is located.

    Patient Dose Documentation Requirements

    Each patient record must document:

    • Exposure;
    • Dose area product (DAP); or
    • Air kerma (AK), where indicated.

    For both pediatric and adult patients, the most common exam technique and resulting dose, as determined annually by the licensed medical physicist, must be displayed at the operator console.

    Questions & Updates

    NYSDA will continue monitoring implementation of these regulations and will provide additional guidance as more information becomes available regarding accreditation requirements and compliance resources.

    Members with questions about the new CBCT regulations can contact NYSDA for additional assistance: info@nysdental.org | (518) 465-0044