The following data is part of a premarket notification filed by Degussa Ag with the FDA for Mixomat Amalgamator.
| Device ID | K914341 |
| 510k Number | K914341 |
| Device Name: | MIXOMAT AMALGAMATOR |
| Classification | Amalgamator, Dental, Ac-powered |
| Applicant | DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
| Contact | Joe Richter |
| Correspondent | Joe Richter DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
| Product Code | EFD |
| CFR Regulation Number | 872.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-27 |
| Decision Date | 1991-11-13 |