The following data is part of a premarket notification filed by Dmg Chemisch Pharmazeutische Fabrik Gmbh with the FDA for Luxatemp Automix.
| Device ID | K924830 |
| 510k Number | K924830 |
| Device Name: | LUXATEMP AUTOMIX |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH ELBGAUSTRABE 148 2000 HAMBURG 53 Germany, GR |
| Contact | Giesen) |
| Correspondent | Giesen) DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH ELBGAUSTRABE 148 2000 HAMBURG 53 Germany, GR |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-25 |
| Decision Date | 1994-04-29 |