Amalgamator, Dental, Ac-Powered
The AC-Powered Dental Amalgamator is a dental device that uses electrical power to mix amalgam alloy powder and mercury in a capsule through high-speed vibration, producing a homogeneous amalgam for use as a tooth filling material. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EFD and the applicable regulation is 21 CFR 872.3100, under the Dental medical specialty.
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Basic Information
- Product Code
- EFD
- Device Class
- FDA class 1
- Regulation Number
- 872.3100
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K991913 | PENTAMIX 2 | Jul 26, 1999 | Substantially Equivalent | Espe Dental AG |
| K923974 | SILIMAT PLUS | Oct 06, 1992 | Substantially Equivalent | Ivoclar North America, Inc. |
| K922203 | IPT CAPSULE MIXER | Jun 03, 1992 | Substantially Equivalent | Ipt Technologies, Inc. |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Mar 02, 1992 | Substantially Equivalent | Kerr Corporation (Danbury) |
| K914341 | MIXOMAT AMALGAMATOR | Nov 13, 1991 | Substantially Equivalent | Degussa AG |
| K914340 | DUOMAT 3 AMALGAMATOR | Nov 13, 1991 | Substantially Equivalent | Degussa AG |
| K914339 | DENTOMAT 3 AMALGAMATORS | Nov 07, 1991 | Substantially Equivalent | Degussa AG |
| K910632 | ACCU-MIX AMALGAMATOR | Mar 15, 1991 | Substantially Equivalent | Wykle Research, Inc. |
| K901909 | SILAMAT (AMALGAMATOR) | Jun 22, 1990 | Substantially Equivalent | Ivoclar North America, Inc. |
| K891612 | DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. | Jun 12, 1989 | Substantially Equivalent | Implant Innovations International, Inc. |
| K891064 | ESPE CAPMIX | May 30, 1989 | Substantially Equivalent | Espe GmbH (Us) |
| K880993 | AMALGAMATOR | May 11, 1988 | Substantially Equivalent | Acecodent, Inc. |
| K791410 | AMALGAMATOR MODEL SDC-- | Sep 19, 1979 | Substantially Equivalent | Sierra Laboratories, Inc. |
| K780560 | DENTAL AMALGAMATOR | Apr 21, 1978 | Substantially Equivalent | L.D. Caulk Co. |
| K771901 | CAPMIX | Oct 20, 1977 | Substantially Equivalent | Espe Dental Products |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.