The following data is part of a premarket notification filed by Denali Corporation with the FDA for Calcium Bridge.
| Device ID | K153191 |
| 510k Number | K153191 |
| Device Name: | Calcium Bridge |
| 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 | No |
| Date Received | 2015-11-03 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8370575000 | K153191 | 000 |
| D8370570000 | K153191 | 000 |