EFD · Amalgamator, Dental, Ac-Powered
Dental · 21 CFR 872.3100 · Class 1
Overview
| Product Code | EFD |
|---|---|
| Device Name | Amalgamator, Dental, Ac-Powered |
| Regulation | 21 CFR 872.3100 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.
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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991913 | PENTAMIX 2 | Espe Dental AG | Jul 26, 1999 | SESE |
| K923974 | SILIMAT PLUS | Ivoclar North America, Inc. | Oct 6, 1992 | SESE |
| K922203 | IPT CAPSULE MIXER | Ipt Technologies, Inc. | Jun 3, 1992 | SESE |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Kerr Corporation (Danbury) | Mar 2, 1992 | SESE |
| K914341 | MIXOMAT AMALGAMATOR | Degussa AG | Nov 13, 1991 | SESE |
| K914340 | DUOMAT 3 AMALGAMATOR | Degussa AG | Nov 13, 1991 | SESE |
| K914339 | DENTOMAT 3 AMALGAMATORS | Degussa AG | Nov 7, 1991 | SESE |
| K910632 | ACCU-MIX AMALGAMATOR | Wykle Research, Inc. | Mar 15, 1991 | SESE |
| K901909 | SILAMAT (AMALGAMATOR) | Ivoclar North America, Inc. | Jun 22, 1990 | SESE |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | Implant Innovations International, Inc. | Jun 12, 1989 | SESE |
| K891064 | ESPE CAPMIX | Espe GmbH (Us) | May 30, 1989 | SESE |
| K880993 | AMALGAMATOR | Acecodent, Inc. | May 11, 1988 | SESE |
| K791410 | AMALGAMATOR MODEL SDC-- | Sierra Laboratories, Inc. | Sep 19, 1979 | SESE |
| K780560 | DENTAL AMALGAMATOR | L.D. Caulk Co. | Apr 21, 1978 | SESE |
| K771901 | CAPMIX | Espe Dental Products | Oct 20, 1977 | SESE |
Top Applicants
- Degussa AG — 3 clearances
- Ivoclar North America, Inc. — 2 clearances
- Wykle Research, Inc. — 1 clearance
- Sierra Laboratories, Inc. — 1 clearance
- L.D. Caulk Co. — 1 clearance
