The following data is part of a premarket notification filed by Toothprints, Inc. with the FDA for Wax Bite Impression Wafer.
| Device ID | K850915 |
| 510k Number | K850915 |
| Device Name: | WAX BITE IMPRESSION WAFER |
| Classification | Wax, Dental, Intraoral |
| Applicant | TOOTHPRINTS, INC. 232 POND ST. Natick, MA 01760 |
| Contact | David A Tesini |
| Correspondent | David A Tesini TOOTHPRINTS, INC. 232 POND ST. Natick, MA 01760 |
| Product Code | EGD |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858290006284 | K850915 | 000 |
| 00858290006314 | K850915 | 000 |