Mixomat Amalgamator
FDA 510(k) K914341 · Degussa AG
510(k) numberK914341
Submission
- Device name
- Mixomat Amalgamator
- Applicant
- Degussa AG
South Plainfield, NJ, US - Received
- September 27, 1991
- Decision date
- November 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EFD
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|---|---|---|---|
| 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 |
| K915847 | Automix Dental AmalgamatorEFD · Traditional | Kerr Corporation (Danbury) | 03/02/1992SE |
| 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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| K972910 | Pors on LiteEJT · Traditional | 10/14/1997SE |
| K960256 | Degudent LSEJT · Traditional | 02/21/1996SE |
| K960226 | DG 88EJT · Traditional | 02/14/1996SE |
| K960104 | Biocclus 4EJT · Traditional | 02/06/1996SE |
| K955465 | DeguprintELW · Traditional | 12/28/1995SE |
| K955118 | Degubond X-Lite PlusEJT · Traditional | 12/11/1995SE |
| K955027 | Degubond X-LiteEJT · Traditional | 12/01/1995SE |
| K953344 | Degubond UltraEJT · Traditional | 08/25/1995SE |
| K951789 | Palliag NF IVEJT · Traditional | 06/14/1995SE |
Questions and answers
When was Mixomat Amalgamator cleared by the FDA?
Mixomat Amalgamator (K914341) received a 510(k) decision of Substantially Equivalent on November 13, 1991, 47 days after the submission was received.
What is the product code of K914341?
The FDA product code is EFD – Amalgamator, Dental, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.3100.