21 CFR 872.6290
§ 872.6290 Prophylaxis cup.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 872.6290, § 872.6290 Prophylaxis cup, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90166
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Full text
(a) Identification. A prophylaxis cup is a device made of rubber intended to be held by a dental handpiece and used to apply polishing agents during prophylaxis (cleaning). The dental handpiece spins the rubber cup holding the polishing agent and the user applies it to the teeth to remove debris.
(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.