CFR
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872.3110—Dental amalgam capsule.
(a) Identification.
A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam.
(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.
Code of Federal Regulations
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