The following data is part of a premarket notification filed by Detax Gmbh & Co. Kg with the FDA for Tempofit, Model 02693.
| Device ID | K994012 |
| 510k Number | K994012 |
| Device Name: | TEMPOFIT, MODEL 02693 |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DETAX GMBH & CO. KG 7707 E. 201 TERR Belton, MO 64012 |
| Contact | Barry Hale |
| Correspondent | Barry Hale DETAX GMBH & CO. KG 7707 E. 201 TERR Belton, MO 64012 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-26 |
| Decision Date | 2000-02-16 |