Automix Dental Amalgamator
FDA 510(k) K915847 · Kerr Corporation (Danbury)
510(k) numberK915847
Submission
- Device name
- Automix Dental Amalgamator
- Applicant
- Kerr Corporation (Danbury)
Romulus, MI, US - Received
- December 26, 1991
- Decision date
- March 2, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EFD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991913 | Pentamix 2EFD · Traditional | Espe Dental AG | 07/26/1999SE |
| K923974 | Silimat PlusEFD · Traditional | Ivoclar North America, Inc. | 10/06/1992SE |
| K922203 | Ipt Capsule MixerEFD · Traditional | Ipt Technologies, Inc. | 06/03/1992SE |
| K914341 | Mixomat AmalgamatorEFD · Traditional | Degussa AG | 11/13/1991SE |
| K914340 | Duomat 3 AmalgamatorEFD · Traditional | Degussa AG | 11/13/1991SE |
| K914339 | Dentomat 3 AmalgamatorsEFD · Traditional | Degussa AG | 11/07/1991SE |
| K910632 | Accu-Mix AmalgamatorEFD · Traditional | Wykle Research, Inc. | 03/15/1991SE |
| K901909 | Silamat (Amalgamator)EFD · Traditional | Ivoclar North America, Inc. | 06/22/1990SE |
| K891612 | Drilling Machine W/Handpieces & Internal Irriga.EFD · Traditional | Implant Innovations International, Inc. | 06/12/1989SE |
| K891064 | Espe CapmixEFD · Traditional | Espe GmbH (Us) | 05/30/1989SE |
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| K051545 | L.E. Demetron IIEBZ · Traditional | 07/18/2005SE |
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| K951663 | Tytin REJJ · Traditional | 06/06/1995SE |
| K951511 | Tytin AdmixEJJ · Traditional | 05/02/1995SE |
| K942480 | M4 Contra-Angle HandpieceEGS · Traditional | 01/27/1995SE |
| K940513 | OptibondKLE · Traditional | 04/15/1994SE |
| K935535 | TytinEJJ · Traditional | 03/11/1994SE |
| K934690 | Kerr Optibond, ModificationKLE · Traditional | 12/30/1993SE |
| K923546 | OptibondKLE · Traditional | 09/29/1992SE |
| K904756 | MatricsESD · Traditional | 03/15/1991SE |
Questions and answers
When was Automix Dental Amalgamator cleared by the FDA?
Automix Dental Amalgamator (K915847) received a 510(k) decision of Substantially Equivalent on March 2, 1992, 67 days after the submission was received.
What is the product code of K915847?
The FDA product code is EFD – Amalgamator, Dental, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.3100.