Title 21: Food and Drugs
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/ PART 872 - DENTAL DEVICES
/ Subpart E - Surgical Devices / § 872.4535 Dental diamond instrument.
§ 872.4535 Dental diamond instrument.
(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.