21 C.F.R. § 872.4535

Dental diamond instrument.

Last amended: 2016Year: 2026Length: 95 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 872.4535 (2026)

(a) Identification. A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994]
21 C.F.R. § 872.4535: Dental diamond instrument. | Justis AI