The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Tempfx Esthetic Provisional System.
| Device ID | K061264 |
| 510k Number | K061264 |
| Device Name: | TEMPFX ESTHETIC PROVISIONAL SYSTEM |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST., SE 60 SUSQUEHANNA COMMERCE CTR. York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST., SE 60 SUSQUEHANNA COMMERCE CTR. York, PA 17404 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-05 |
| Decision Date | 2006-05-23 |
| Summary: | summary |