H.B. No. 4070 amends the Health and Safety Code by adding Section 431.024, which establishes regulations for the sale, design, and manufacture of orthodontic devices in Texas. The bill defines "orthodontic device" as any class II or III medical device used in orthodontic treatment, excluding retainers, and specifies that only licensed dentists or those with written confirmation from a dentist can sell or provide services related to these devices. It mandates that patients must undergo an in-person dental examination, review of diagnostic imaging, and receive a prescription from a dentist before any orthodontic device can be sold or designed for them. Additionally, the bill requires that patients acknowledge receiving counseling about treatment options and risks, and that all related documents be maintained for at least seven years.
The bill also includes provisions to ensure that dentists cannot require patients to agree to a specific type of orthodontic device as a condition for examination, and it allows for the transfer of dental records between dentists under certain conditions. The new regulations will apply only to services and devices sold after the effective date of the Act, which is set for September 1, 2025. This ensures that any transactions or services provided before this date will continue to be governed by the existing laws.
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