21 C.F.R. § 872.4535
Dental diamond instrument.
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]