DZS · Capsule, Dental, Amalgam
Dental · 21 CFR 872.3110 · Class 1
Overview
| Product Code | DZS |
|---|---|
| Device Name | Capsule, Dental, Amalgam |
| Regulation | 21 CFR 872.3110 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K822610 | PRECAPSULED DENTAL AMALGAM | Syntex Dental Products, Inc. | Sep 14, 1982 | SESE |
| K802967 | DISPERSALLOY-DISPERSED PHASE ALLOY SELF- | Johnson & Johnson Professionals, Inc. | Dec 30, 1980 | SESE |
| K781243 | MERCURY DISP. CAPSULE | Lee Pharmaceuticals | Sep 20, 1978 | SESE |
| K780966 | LEE-ALLOY DISPOSABLE CAPSULES | Lee Pharmaceuticals | Aug 21, 1978 | SESE |
Top Applicants
- Lee Pharmaceuticals — 2 clearances
- Syntex Dental Products, Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
