Relating to the sale, design, and manufacture of orthodontic devices, the official text

H.B. No. 4070

AN ACT

relating to the sale, design, and manufacture of orthodontic

devices.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Subchapter B, Chapter 431, Health and Safety

Code, is amended by adding Section 431.024 to read as follows:

Sec. 431.024. ORTHODONTIC DEVICES. (a) In this section:

(1) "Orthodontic device" means any class II or class

III medical device, as defined by the United States Food and Drug

Administration under 21 U.S.C. Section 360c and 21 C.F.R. Section

860.3, excluding a retainer used to keep teeth in a fixed position,

that is:

(A) used in orthodontic treatment to move a

patient's teeth or jaw or correct a misalignment or malposition;

and

(B) manufactured to address the specific

orthodontic needs of an individual patient.

(2) "Dentist" means a person licensed to practice

dentistry in this state under Subtitle D, Title 3, Occupations

Code.

(b) A person may not sell an orthodontic device to a patient

in this state or provide a service related to the design or

manufacture of an orthodontic device unless the person:

(1) is a dentist who has provided the services

prescribed by Subsection (c) to the patient; or

(2) receives written or electronic confirmation from a

dentist who has provided the services prescribed by Subsection (c)

to the patient.

(c) A person may 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:

(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 dentist to

detect patient conditions that preclude or contraindicate the

provision of safe orthodontic treatment, including:

(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;

or

(F) any other oral pathology or condition that

precludes orthodontic treatment;

(3) a prescription for an orthodontic device issued

by:

(A) the dentist who provided the examination

described by Subdivision (1) and reviewed the appropriate

diagnostic imaging described by Subdivision (2); or

(B) the dentist who:

(i) will conduct and monitor the patient's

orthodontic treatment; and

(ii) has either:

(a) received a referral from the

patient's dentist described by Paragraph (A); or

(b) requested, received, and

maintained clearance for orthodontic treatment from the patient's

dentist described by Paragraph (A);

(4) subject to Subsection (d), counsel by a dentist

described by Subdivision (3) regarding available orthodontic

treatment options and the risks associated with those treatments;

and

(5) a review of the patient's medical and dental health

histories.

(d) The required counsel under Subsection (c)(4) is valid

only if the patient acknowledges and verifies in writing, with the

patient's signature, that the patient received the counsel. The

dentist providing the required counsel shall attach and maintain

the patient's written acknowledgment of counsel in the patient's

file.

(e) A person who sells an orthodontic device to a patient or

provides a service related to the design or manufacture of an

orthodontic device shall maintain any documents received under

Subsection (c) for not less than seven years after the date of sale

or provision of services.

(f) A dentist may not require a patient to agree to use a

particular type of orthodontic device as a condition of performing

the examination or review described by Subsections (c)(1) and

(c)(2).

(g) A dentist described by Subsection (c)(3)(A) shall

provide any records collected under Subsections (c)(1) and (c)(2)

to another dentist in accordance with Section 258.109, Occupations

Code, if:

(1) disclosure of a dental record is authorized under

Subchapter C, Chapter 258, Occupations Code; and

(2) the other dentist requests the records.

SECTION 2. Section 431.024, Health and Safety Code, as

added by this Act, applies only to services related to the design or

manufacture of an orthodontic device that are provided or an

orthodontic device sold on or after the effective date of this Act.

Services related to the design or manufacture of an orthodontic

device that are provided or an orthodontic device sold before the

effective date of this Act are governed by the law in effect

immediately before the effective date of this Act, and that law is

continued in effect for that purpose.

SECTION 3. This Act takes effect September 1, 2025.

______________________________
______________________________

President of the Senate
Speaker of the House

I certify that H.B. No. 4070 was passed by the House on May

14, 2025, by the following vote: Yeas 91, Nays 49, 2 present, not

voting.

______________________________

Chief Clerk of the House

I certify that H.B. No. 4070 was passed by the Senate on May

27, 2025, by the following vote: Yeas 28, Nays 3.

______________________________

Secretary of the Senate

APPROVED: _____________________

Date

_____________________

Governor