21 CFR 872.3110 — Capsule, Dental, Amalgam
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3110
Identification
A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam.
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 |
|---|---|---|---|---|
| DZS | Capsule, Dental, Amalgam | 1 | 4 |
