21 CFR 872.3100 — Amalgamator, Dental, Ac-Powered

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3100

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
EFDAmalgamator, Dental, Ac-Powered115
Innolitics

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