The following data is part of a premarket notification filed by Prime Dental Manufacturing, Inc. with the FDA for Prime-dent Dual Cure Composite Luting Cement.
| Device ID | K112574 |
| 510k Number | K112574 |
| Device Name: | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT |
| Classification | Cement, Dental |
| Applicant | PRIME DENTAL MANUFACTURING, INC. 4555 WEST ADDISON STREET Chicago, IL 60641 |
| Contact | Javier Alvarez |
| Correspondent | Javier Alvarez PRIME DENTAL MANUFACTURING, INC. 4555 WEST ADDISON STREET Chicago, IL 60641 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-06 |
| Decision Date | 2012-01-23 |