510(k) K991913
- Device
- PENTAMIX 2
- Applicant
- ESPE DENTAL AG
- 510(k) number
- K991913
- Product code
- EFD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-07-26
- Date received
- 1999-06-07
- Regulation
- 872.3100
- Classification name
- Amalgamator, Dental, Ac-powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- A. PETERMANN
- Address
- Espe Platz Bavaria D-82228 Seefeld DE D-82229 D-82229
FDA Registration Numbers#
- 9611385
- 3008559238
- 2024312
- 2031508
- 3005176727
- 8044164
- 3001065024
- 3008530360
- 9612352
- 3010864832
- 3014953747
- 3014326245
- 9612300
- 3004966444
- 1216602
- 3035693034
- 8010908
- 2424472
- 1000493628
- 2020703
- 3009171220
- 3005665377
- 3003018722
- 3003169405
- 2244812
- 1410097
- 3009496224
- 3006552587
- 9616103
- 2018957
- 3004140838
Source Documents#
Other 510(k) Records For Product Code EFD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923974 | SILIMAT PLUS | Ivoclar North America, Inc. | 1992-10-06 |
| K922203 | IPT CAPSULE MIXER | Ipt Technologies, Inc. | 1992-06-03 |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Kerr Corporation (Danbury) | 1992-03-02 |
| K914340 | DUOMAT 3 AMALGAMATOR | Degussa AG | 1991-11-13 |
| K914341 | MIXOMAT AMALGAMATOR | Degussa AG | 1991-11-13 |
| K914339 | DENTOMAT 3 AMALGAMATORS | Degussa AG | 1991-11-07 |
| K910632 | ACCU-MIX AMALGAMATOR | Wykle Research, Inc. | 1991-03-15 |
| K901909 | SILAMAT (AMALGAMATOR) | Ivoclar North America, Inc. | 1990-06-22 |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | Implant Innovations International, Inc. | 1989-06-12 |
| K891064 | ESPE CAPMIX | Espe GmbH (Us) | 1989-05-30 |
| K880993 | AMALGAMATOR | Acecodent, Inc. | 1988-05-11 |
| K791410 | AMALGAMATOR MODEL SDC-- | Sierra Laboratories, Inc. | 1979-09-19 |
| K780560 | DENTAL AMALGAMATOR | L.D. Caulk Co. | 1978-04-21 |
| K771901 | CAPMIX | Espe Dental Products | 1977-10-20 |
Legacy Summary#
summary
FDA Review#
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