E-Denture Pro
Resin, Denture, Relining, Repairing, Rebasing
EnvisionTEC GmbH
The following data is part of a premarket notification filed by Envisiontec Gmbh with the FDA for E-denture Pro.
Pre-market Notification Details
| Device ID | K203641 |
| 510k Number | K203641 |
| Device Name: | E-Denture Pro |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | EnvisionTEC GmbH Brusseler Straße 51 Gladbeck, DE D-45968 |
| Contact | Ruediger Van Bernum |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-14 |
| Decision Date | 2021-03-30 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260683220386 | K203641 | 000 |
| 04260683220379 | K203641 | 000 |
| 04260683220362 | K203641 | 000 |
| 04260683220355 | K203641 | 000 |
| 04260683220348 | K203641 | 000 |
Trademark Results [E-Denture Pro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 E-DENTURE PRO 90614790 not registered Live/Pending |
Envisiontec US LLC 2021-03-31 |
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