Code of Federal Regulations · Section

§ 872.3830 — Endodontic Paper Point

21 C.F.R. § 872.3830

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(a) Identification. An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry, or apply medication to, the root canal of a tooth.

(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.

Authorizing Statute