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Title 21 → Chapter I → Subchapter H → Part 872 → Subpart D → §872.3100

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Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices

§872.3100 Dental amalgamator.

(a) Identification. A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001]

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