Code of Federal Regulations · Section
§ 872.3080 — Mercury And Alloy Dispenser
21 C.F.R. § 872.3080
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(a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.
(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351