The following data is part of a premarket notification filed by Denali Corporation with the FDA for Cercom Ii Cement.
| Device ID | K132393 |
| 510k Number | K132393 |
| Device Name: | CERCOM II 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 | 2013-08-01 |
| Decision Date | 2014-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8370655510 | K132393 | 000 |
| D8375210100 | K132393 | 000 |
| D8375210500 | K132393 | 000 |
| D8375210600 | K132393 | 000 |
| D74570BZDC0 | K132393 | 000 |
| D8370652000 | K132393 | 000 |
| D8370652100 | K132393 | 000 |
| D8370652200 | K132393 | 000 |
| D8370655500 | K132393 | 000 |
| D8375210000 | K132393 | 000 |