21 CFR 872.5525
§ 872.5525 Preformed tooth positioner.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.5525, § 872.5525 Preformed tooth positioner, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90148
- Permanent ID
ys:prov:90148@1- SHA-256
93a0a58f83e0d39bb5297d8df12f8d16131a2a74abcb4b65098eaa85a0ef5bec
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.