Amalgamator, Dental, Ac-Powered
Regulation 872.3100
0510(k)s in 12 months (15 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EFD
| Company | 510(k)s | Recalls |
|---|---|---|
| Degussa AG | 3 | 0 |
| Ivoclar North America, Inc. | 2 | 0 |
| Acecodent, Inc. | 1 | 0 |
| Espe Dental AG | 1 | 0 |
| Espe Dental Products | 1 | 0 |
| Espe GmbH (Us) | 1 | 0 |
| Implant Innovations International, Inc. | 1 | 0 |
| Ipt Technologies, Inc. | 1 | 0 |
| Kerr Corporation (Danbury) | 1 | 0 |
| L.D. Caulk Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 1999 | K991913 | PENTAMIX 2 Espe Dental AG, DE | EFD |
| Oct 6, 1992 | K923974 | SILIMAT PLUS Ivoclar North America, Inc. | EFD |
| Jun 3, 1992 | K922203 | IPT CAPSULE MIXER Ipt Technologies, Inc. | EFD |
| Mar 2, 1992 | K915847 | AUTOMIX DENTAL AMALGAMATOR Kerr Corporation (Danbury) | EFD |
| Nov 13, 1991 | K914341 | MIXOMAT AMALGAMATOR Degussa AG | EFD |
| Nov 13, 1991 | K914340 | DUOMAT 3 AMALGAMATOR Degussa AG | EFD |
| Nov 7, 1991 | K914339 | DENTOMAT 3 AMALGAMATORS Degussa AG | EFD |
| Mar 15, 1991 | K910632 | ACCU-MIX AMALGAMATOR Wykle Research, Inc. | EFD |
| Jun 22, 1990 | K901909 | SILAMAT (AMALGAMATOR) Ivoclar North America, Inc. | EFD |
| Jun 12, 1989 | K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. Implant Innovations International, Inc. | EFD |
| May 30, 1989 | K891064 | ESPE CAPMIX Espe GmbH (Us) | EFD |
| May 11, 1988 | K880993 | AMALGAMATOR Acecodent, Inc. | EFD |
| Sep 19, 1979 | K791410 | AMALGAMATOR MODEL SDC-- Sierra Laboratories, Inc. | EFD |
| Apr 21, 1978 | K780560 | DENTAL AMALGAMATOR L.D. Caulk Co. | EFD |
| Oct 20, 1977 | K771901 | CAPMIX Espe Dental Products | EFD |
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