21 CFR 872.3140
§ 872.3140 Resin applicator.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.3140, § 872.3140 Resin applicator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90066
- Permanent ID
ys:prov:90066@1- SHA-256
10ba5117a8bc54caf5ad92933d6c9f45ca79d81b5221f8b5d97ceaee75d791d3
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material.
(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, the device 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.