The following data is part of a premarket notification filed by Vertex-dental B.v. with the FDA for Vertex Thermosens Rigid.
| Device ID | K123220 |
| 510k Number | K123220 |
| Device Name: | VERTEX THERMOSENS RIGID |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VERTEX-DENTAL B.V. 154 MAIN ST. Charlestown, NH 03603 |
| Contact | Mason Diamond |
| Correspondent | Mason Diamond VERTEX-DENTAL B.V. 154 MAIN ST. Charlestown, NH 03603 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2013-03-01 |
| Summary: | summary |