The following data is part of a premarket notification filed by Denali Corporation with the FDA for Auravue Pit & Fissure Sealant.
| Device ID | K070693 |
| 510k Number | K070693 |
| Device Name: | AURAVUE PIT & FISSURE SEALANT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENALI CORPORATION 134 OLD WASHINGTON STREET Hanover, MA 02339 |
| Contact | Jan G Stannard |
| Correspondent | Jan G Stannard DENALI CORPORATION 134 OLD WASHINGTON STREET Hanover, MA 02339 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-03-13 |
| Decision Date | 2007-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D820CV0 | K070693 | 000 |
| D820APS0 | K070693 | 000 |