§ 872.4535. Dental diamond instrument.
95 words·~1 min read·
/us/cfr/t21/s§ 872.4535·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]