The following data is part of a premarket notification filed by Denali Corporation with the FDA for Auraveneer Cement.
| Device ID | K073101 |
| 510k Number | K073101 |
| Device Name: | AURAVENEER CEMENT |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-16 |
| Decision Date | 2008-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8370656050 | K073101 | 000 |
| D8370650100 | K073101 | 000 |
| D8370650200 | K073101 | 000 |
| D8370650300 | K073101 | 000 |
| D8370651050 | K073101 | 000 |
| D8370651150 | K073101 | 000 |
| D8370655000 | K073101 | 000 |
| D8370655100 | K073101 | 000 |
| D8370655200 | K073101 | 000 |
| D8370656000 | K073101 | 000 |
| D8370650000 | K073101 | 000 |