The following data is part of a premarket notification filed by Denali Corporation with the FDA for Auralay Pit & Fissure Sealant.
| Device ID | K071158 |
| 510k Number | K071158 |
| Device Name: | AURALAY PIT & FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-25 |
| Decision Date | 2007-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D820BONOW1 | K071158 | 000 |
| D820ALAYNT3ML0 | K071158 | 000 |
| D820ALAYOW0 | K071158 | 000 |
| D820ALAYOW3ML0 | K071158 | 000 |
| D820ALAYXFNT0 | K071158 | 000 |
| D820ALAYXFNT3ML0 | K071158 | 000 |
| D820ALAYXFOW0 | K071158 | 000 |
| D820ALAYXFOW3ML0 | K071158 | 000 |
| D820BONNT0 | K071158 | 000 |
| D820ALAYNT0 | K071158 | 000 |