The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for Automix Dental Amalgamator.
| Device ID | K915847 |
| 510k Number | K915847 |
| Device Name: | AUTOMIX DENTAL AMALGAMATOR |
| Classification | Amalgamator, Dental, Ac-powered |
| Applicant | KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174 |
| Contact | Benjamin Weaver |
| Correspondent | Benjamin Weaver KERR CORPORATION (DANBURY) 28200 WICK RD P.O. BOX 455 Romulus, MI 48174 |
| Product Code | EFD |
| CFR Regulation Number | 872.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-26 |
| Decision Date | 1992-03-02 |