The following data is part of a premarket notification filed by Detax Gmbh & Co. Kg with the FDA for Detax Implantlink Semi.
| Device ID | K100247 |
| 510k Number | K100247 |
| Device Name: | DETAX IMPLANTLINK SEMI |
| Classification | Cement, Dental |
| Applicant | DETAX GMBH & CO. KG AMSTEL 320-I Amsterdam, NL D-76275 |
| Contact | Dagmar Maeser |
| Correspondent | Dagmar Maeser DETAX GMBH & CO. KG AMSTEL 320-I Amsterdam, NL D-76275 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-27 |
| Decision Date | 2010-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842092112434 | K100247 | 000 |