Dental diamond instrument.

21 C.F.R. § 872.4535
in effectEffective: 2024-07-01
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(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.

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