21 C.F.R. § 872.5525 Preformed tooth positioner.
Title 21 - Food and Drugs
(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. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart F—Therapeutic Devices
§ 872.5525 Preformed tooth positioner.
