21 C.F.R. § 872.4535 Dental diamond instrument.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart E—Surgical Devices
§ 872.4535 Dental diamond instrument.
