The following data is part of a premarket notification filed by Deltamed Gmbh with the FDA for 3delta Denture Base - 3delta Denture Bond - 3delta Denture Fix.
| Device ID | K212541 |
| 510k Number | K212541 |
| Device Name: | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DeltaMed GmbH Raiffeisenstrasse 8a Friedberg, DE 61169 |
| Contact | Michael Zimmermann |
| Correspondent | Gary Chuven Cosmedent Inc. 401 North Michigan Ave. Suite 2500 Chicago, IL 60611 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-12 |
| Decision Date | 2022-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDEL16069500 | K212541 | 000 |
| 04260635981341 | K212541 | 000 |
| 04260635981358 | K212541 | 000 |
| 04260635981365 | K212541 | 000 |
| 04260635981372 | K212541 | 000 |
| EDEL16060100 | K212541 | 000 |
| EDEL16060200 | K212541 | 000 |
| EDEL16061100 | K212541 | 000 |
| EDEL16061200 | K212541 | 000 |
| EDEL16069100 | K212541 | 000 |
| EDEL13513500 | K212541 | 000 |