StacksVerified U.S. regulatory reference

21 CFR §872.4535

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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.
  2. (b)Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.