Product code EFD
- Device name
- Amalgamator, Dental, Ac-Powered
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3100
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991913 | PENTAMIX 2 | Espe Dental AG | 1999-07-26 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04054596736351 | 3M™ Imprint™ | 3M Deutschland GmbH | 2026-05-08 |
| 04054596736344 | 3M™ Imprint™ | 3M Deutschland GmbH | 2026-05-08 |
| 04054596736177 | 3M™ Impregum™ | 3M Deutschland GmbH | 2026-05-08 |
| 04054596734142 | 3M™ Penta™ | 3M Deutschland GmbH | 2026-05-08 |
| 04054596734227 | 3M™ Penta™ | 3M Deutschland GmbH | 2026-05-08 |
| 00197998022579 | Solventum™ | Solventum Germany GmbH | 2026-05-08 |
| 00817169023548 | 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | 2022-12-29 |
| D033099551181 | Techno | DMG AMERICA, LLC | 2022-12-09 |
| D033099610331 | Zenith | DMG AMERICA, LLC | 2022-12-09 |
| D033099550161 | Techno | DMG AMERICA, LLC | 2022-12-09 |
| 04054596735712 | 3M™ ESPE™ Impregum™ Penta™ | 3M Deutschland GmbH | 2022-08-02 |
| 04054596735842 | 3M™ ESPE™ Impregum™ | 3M Deutschland GmbH | 2022-08-02 |
| 04054596645738 | 3M™ Imprint™ | 3M Deutschland GmbH | 2022-08-02 |
| 04054596645714 | 3M™ Imprint™ | 3M Deutschland GmbH | 2022-08-02 |
| 04054596582620 | Impregum™ Penta™ Super Quick | 3M Deutschland GmbH | 2018-11-14 |
| 04054596582514 | Impregum™ Penta™ Super Quick | 3M Deutschland GmbH | 2018-11-14 |
| 04054596582477 | Impregum™ Penta™ Super Quick | 3M Deutschland GmbH | 2018-11-14 |
| 04035077005753 | Impregum™ Penta™ Soft Quick Step Heavy Body | 3M Deutschland GmbH | 2017-08-04 |
| 04035077007801 | Imprint™ 4 Penta™ Super Quick Heavy | 3M Deutschland GmbH | 2017-08-04 |
| 04035077005791 | Impregum™ Penta™ Soft Heavy Body | 3M Deutschland GmbH | 2017-08-04 |
| 04035077004404 | Impregum™ Penta™ Soft Medium Body | 3M Deutschland GmbH | 2017-08-04 |
| 04035077004381 | Impregum™ Penta™ | 3M Deutschland GmbH | 2017-08-04 |
| D0470036801 | CAPSULE MIXER CM-II | Gc America Inc. | 2017-01-24 |
| J001702011022020 | RotoMix™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011415150 | Imprint™ 4 Penta™ Putty | 3M Deutschland GmbH | 2016-09-24 |
| J001702011414990 | Imprint™ 4 Penta™ Heavy | 3M Deutschland GmbH | 2016-09-24 |
| J001702011379760 | Impregum™ Penta™ Soft Heavy Body | 3M Deutschland GmbH | 2016-09-24 |
| J001702011379190 | Impregum™ Penta™ Soft Quick Step Heavy Body | 3M Deutschland GmbH | 2016-09-24 |
| J001702011328110 | Impregum™ Penta™ Soft Medium Body | 3M Deutschland GmbH | 2016-09-24 |
| J001702011327870 | Impregum™ Penta™ | 3M Deutschland GmbH | 2016-09-24 |