The following data is part of a premarket notification filed by Vertex-dental Bv with the FDA for Nextdent Denture, E-denture.
| Device ID | K162572 |
| 510k Number | K162572 |
| Device Name: | NextDent Denture, E-Denture |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VERTEX-DENTAL BV JOHAN VAN OLDENBARNEVELTLAAN 62 Zeist, NL 3705 Hj |
| Contact | O. F. Beckeringh Van Loenen |
| Correspondent | Patsy J. Trisler Qserve Group US Inc. 5600 WISCONSIN AVENUE Chevy Chase, MD 20815 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2017-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719425508597 | K162572 | 000 |
| 08719425508498 | K162572 | 000 |
| 08719425508504 | K162572 | 000 |
| 08719425508511 | K162572 | 000 |
| 08719425508528 | K162572 | 000 |
| 08719425508535 | K162572 | 000 |
| 08719425508542 | K162572 | 000 |
| 08719425508559 | K162572 | 000 |
| 08719425508566 | K162572 | 000 |
| 08719425508573 | K162572 | 000 |
| 08719425508580 | K162572 | 000 |
| 08719425508481 | K162572 | 000 |