E-Dent 1000
Material, Tooth Shade, Resin
EnvisionTEC GmbH
The following data is part of a premarket notification filed by Envisiontec Gmbh with the FDA for E-dent 1000.
Pre-market Notification Details
| Device ID | K210977 |
| 510k Number | K210977 |
| Device Name: | E-Dent 1000 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | EnvisionTEC GmbH Brusseler Strabe 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 | EBF |
| Subsequent Product Code | EBI |
| Subsequent Product Code | ELM |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-01 |
| Decision Date | 2021-05-25 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260683220959 | K210977 | 000 |
| 04260683220942 | K210977 | 000 |
| 04260683220935 | K210977 | 000 |
| 04260683220928 | K210977 | 000 |
| 04260683220911 | K210977 | 000 |
Trademark Results [E-Dent 1000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 E-DENT 1000 90614911 not registered Live/Pending |
Envisiontec US LLC 2021-03-31 |
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