The following data is part of a premarket notification filed by Dentsply Interntional with the FDA for Modified Temprx Esthetic Provisional System.
| Device ID | K080311 |
| 510k Number | K080311 |
| Device Name: | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-04-18 |
| Summary: | summary |