The following data is part of a premarket notification filed by Deltamed Gmbh with the FDA for P Pro Crown & Bridge.
| Device ID | K200039 |
| 510k Number | K200039 |
| Device Name: | P Pro Crown & Bridge |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DeltaMed GmbH Raiffeisenstrasse 8a Friedberg, DE 61169 |
| Contact | Michael Zimmerman |
| Correspondent | Gary Chuven Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago, IL 60611 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-08 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260635980320 | K200039 | 000 |
| 04260635980290 | K200039 | 000 |
| 04260635980269 | K200039 | 000 |
| EDEL16110300 | K200039 | 000 |
| EDEL16110200 | K200039 | 000 |
| EDEL16110100 | K200039 | 000 |