The following data is part of a premarket notification filed by Vertex-dental Bv with the FDA for Nextdent Denture 3d+.
| Device ID | K191497 |
| 510k Number | K191497 |
| Device Name: | NextDent Denture 3D+ |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | Vertex-Dental BV Centurionbaan 190 Soesterberg, NL 3769 Av |
| Contact | Loes Vloet-emonts |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-05 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719425509198 | K191497 | 000 |
| 08720604633689 | K191497 | 000 |
| 08720604633696 | K191497 | 000 |
| 08720604633719 | K191497 | 000 |
| 08720604633726 | K191497 | 000 |
| 08720604633733 | K191497 | 000 |
| 08719425509570 | K191497 | 000 |
| 08719425509587 | K191497 | 000 |
| 08719425508870 | K191497 | 000 |
| 08719425508887 | K191497 | 000 |
| 08719425508894 | K191497 | 000 |
| 08719425508900 | K191497 | 000 |
| 08719425508917 | K191497 | 000 |
| 08719425509150 | K191497 | 000 |
| 08719425509167 | K191497 | 000 |
| 08719425509174 | K191497 | 000 |
| 08719425509181 | K191497 | 000 |
| 08720604633658 | K191497 | 000 |