AMALGAMATOR MODEL SDC--
FDA 510(k) clearance K791410 · decided 1979-09-19
Clearance details
- K-number
- K791410
- Device name
- AMALGAMATOR MODEL SDC--
- Applicant
- Sierra Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-12
- Decision date
- 1979-09-19
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- EFD
- Device class
- 1
- Regulation number
- 872.3100
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.