The following data is part of a premarket notification filed by Dentsply Interntional with the FDA for Self-adhesive Resin Cement.
| Device ID | K073173 |
| 510k Number | K073173 |
| Device Name: | SELF-ADHESIVE RESIN CEMENT |
| Classification | Cement, Dental |
| Applicant | DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17404 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2008-01-23 |
| Summary: | summary |