AN ACT to require an in‑person evaluation for patients prior to orthodontic device services.

The General Assembly of North Carolina enacts:

SECTION 1.  Article 2 of Chapter 90 is amended by adding a new section to read:

§ 90‑29.6.  Certain orthodontic device and treatment requirements.

(a)        Definitions. – The following definitions apply in this section:

(1)        Licensed dentist. – As defined in G.S. 90‑30.2(a).

(2)        Orthodontic device. – Any Class II or Class III medical device, as defined by 21 U.S.C. § 360c and 21 CFR § 860.3 that meets all of the following:

a.         Used in orthodontic treatment to (i) move a patient's teeth or jaw or (ii) correct a misalignment or malposition.

b.         Manufactured to address the specific orthodontic needs of an individual patient.

(b)        Limitation. – A person shall not sell an orthodontic device or provide a service related to the design or manufacture of an orthodontic device to a patient, unless the person is a licensed dentist who is in compliance with subsection (c) of this section, or receives written or electronic confirmation from a licensed dentist who has provided the services prescribed in subsection (c) of this section.

(c)        Criteria. – A person shall not sell an orthodontic device or provide a service related to the design or manufacture of an orthodontic device to a patient in this State who has not received all of the following:

(1)        An in‑person intraoral dental examination and an examination of the patient's head and neck.

(2)        A review of recently performed x‑rays, panoramic x‑rays, computed tomography, bone imaging scans, or other appropriate diagnostic imaging sufficient to allow the licensed dentist to detect the patient conditions that preclude or contraindicate the provision of safe orthodontic treatment, including the following:

a.         Untreated caries.

b.         Gingivitis and periodontal disease.

c.         Issues with the roots of teeth in the periodontium, including short roots.

d.         The presence of an osseointegrated dental implant or other fixed dental appliance.

e.         Fractured, cracked, or split teeth or roots.

f.          Any other oral pathology or condition that precludes orthodontic treatment.

(3)        A prescription for an orthodontic device issued by either of the following:

a.         The licensed dentist who (i) provided the examination under subdivision (1) of this subsection and (ii) reviewed the appropriate diagnostic imaging under subdivision (2) of this subsection.

b.         The licensed dentist who (i) will conduct and monitor the patient's orthodontic treatment and (ii) has received or requested either of the following:

1.         A referral from the patient's licensed dentist under subdivision (1) of this subsection.

2.         Clearance for orthodontic treatment from the patient's licensed dentist.

(4)        Subject to subsection (d) of this section, advice and counsel by a licensed dentist under subdivision (3) of this subsection regarding available orthodontic treatment options and the risks associated with those treatments.

(5)        A review of the patient's medical and dental health histories.

(d)       Consent. – The required advice and counsel under subdivision (c)(4) of this section must be signed by the patient acknowledging and verifying that the patient received the advice and counsel from the licensed dentist. The licensed dentist that provides the advice and counsel shall attach and maintain the patient's written acknowledgement and verification in the patient's file.

(e)        Records. – A licensed dentist shall maintain all records and documents regarding a sale of an orthodontic device to a patient or provision of services related to the design or manufacture of that device for no less than seven years after the date of sale or provision of those services.

(f)        Condition. – A licensed dentist shall not require a patient to agree to use a particular type of orthodontic device as a condition of performing the examination or review described in this section.

(g)        Disclosure of Records. – Upon request of another licensed dentist, the dentist providing an orthodontic device or related services to a patient must disclose and provide any patient records collected under this section in the course of treatment.

SECTION 2.  The North Carolina State Board of Dental Examiners may adopt rules to implement the provisions of this act.

SECTION 3.  There is appropriated from the General Fund to the Department of Health and Human Services, the sum of fifty thousand dollars ($50,000) for the 2026‑2027 fiscal year to educate the public of the provisions of this act. The Department shall consult with the North Carolina State Board of Dental Examiners in educating the public.

SECTION 4. Section 3 of this act becomes effective July 1, 2026. Section 1 of this act becomes effective October 1, 2026. The remainder of this act is effective when it becomes law.