21 CFR 872.3080 — Dispenser, Mercury And/Or Alloy

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3080

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.

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
EHEDispenser, Mercury And/Or Alloy12
Innolitics

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