The following data is part of a premarket notification filed by Detax Gmbh & Co.kg with the FDA for Mollosil Plus.
| Device ID | K162654 |
| 510k Number | K162654 |
| Device Name: | Mollosil Plus |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DETAX GmbH & Co.KG Carl-Zeiss-Str. 4 Ettlingen, DE 76275 |
| Contact | Antje Reeps |
| Correspondent | Antje Reeps DETAX GmbH & Co.KG Carl-Zeiss-Str. 4 Ettlingen, DE 76275 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-23 |
| Decision Date | 2017-03-13 |