The following data is part of a premarket notification filed by Deltamed Gmbh with the FDA for 3delta Crown.
| Device ID | K211804 |
| 510k Number | K211804 |
| Device Name: | 3Delta Crown |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-11 |
| Decision Date | 2021-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDEL16112600 | K211804 | 000 |
| EDEL16111550 | K211804 | 000 |
| EDEL16111500 | K211804 | 000 |
| 04260635981303 | K211804 | 000 |
| 04260635981297 | K211804 | 000 |
| 04260635981280 | K211804 | 000 |
| 04260635981273 | K211804 | 000 |
| 04260635981266 | K211804 | 000 |
| 04260635981259 | K211804 | 000 |
| EDEL16112500 | K211804 | 000 |
| EDEL16112550 | K211804 | 000 |
| EDEL16111100 | K211804 | 000 |
| EDEL16112350 | K211804 | 000 |
| EDEL16112300 | K211804 | 000 |
| EDEL16112200 | K211804 | 000 |
| EDEL16112100 | K211804 | 000 |
| EDEL16111600 | K211804 | 000 |
| EDEL16111350 | K211804 | 000 |
| EDEL16111300 | K211804 | 000 |
| EDEL16111200 | K211804 | 000 |
| 04260635981242 | K211804 | 000 |