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Title 21 → Chapter I → Subchapter H → Part 872 → Subpart E → §872.4535 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart E—Surgical Devices
§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.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994]