EFD
15 FDA 510(k) clearances · Product code
49 daysmedian time to decision
84 days90th percentile
15clearances measured
FDA profile
- Official device name
- Amalgamator, Dental, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3100
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PENTAMIX 2 (K991913) | Espe Dental AG | 1999-07-26 |
| SILIMAT PLUS (K923974) | Ivoclar North America, Inc. | 1992-10-06 |
| IPT CAPSULE MIXER (K922203) | Ipt Technologies, Inc. | 1992-06-03 |
| AUTOMIX DENTAL AMALGAMATOR (K915847) | Kerr Corporation (Danbury) | 1992-03-02 |
| DUOMAT 3 AMALGAMATOR (K914340) | Degussa AG | 1991-11-13 |
| MIXOMAT AMALGAMATOR (K914341) | Degussa AG | 1991-11-13 |
| DENTOMAT 3 AMALGAMATORS (K914339) | Degussa AG | 1991-11-07 |
| ACCU-MIX AMALGAMATOR (K910632) | Wykle Research, Inc. | 1991-03-15 |
| SILAMAT (AMALGAMATOR) (K901909) | Ivoclar North America, Inc. | 1990-06-22 |
| DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. (K891612) | Implant Innovations International, Inc. | 1989-06-12 |
| ESPE CAPMIX (K891064) | Espe GmbH (Us) | 1989-05-30 |
| AMALGAMATOR (K880993) | Acecodent, Inc. | 1988-05-11 |
| AMALGAMATOR MODEL SDC-- (K791410) | Sierra Laboratories, Inc. | 1979-09-19 |
| DENTAL AMALGAMATOR (K780560) | L.D. Caulk Co. | 1978-04-21 |
| CAPMIX (K771901) | Espe Dental Products | 1977-10-20 |
Track EFD automatically
Every clearance here is in the API, with alerts when new ones post.