21 CFR 872.6570
§ 872.6570 Impression tube.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.6570, § 872.6570 Impression tube, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90172
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Full text
(a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the tooth to make the impression.
(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.