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e-CFR Data is current as of February 12, 2009


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart G—Miscellaneous Devices

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§ 872.6080   Airbrush.

(a) Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

(b) Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601–1–AM2 (1995–03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

[52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. 30, 1987, as amended at 71 FR 17144, Mar. 31, 2006]

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