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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EHE | Dispenser, Mercury And/Or Alloy | 1 | 2 |