Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart F - Therapeutic Devices / § 872.5525 Preformed tooth positioner.
§ 872.5525 Preformed tooth positioner.
(a) Identification. A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.