The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Permacem / Permacem Dual.
| Device ID | K012316 |
| 510k Number | K012316 |
| Device Name: | PERMACEM / PERMACEM DUAL |
| Classification | Cement, Dental |
| Applicant | DMG USA, INC. 414 SOUTH STATE ST. Dover, DE 19901 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG USA, INC. 414 SOUTH STATE ST. Dover, DE 19901 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-23 |
| Decision Date | 2001-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG1105258 | K012316 | 000 |