The following data is part of a premarket notification filed by Dentsply Interntional with the FDA for Pre-cemented Orthodontic Bracket System Extension.
| Device ID | K081291 |
| 510k Number | K081291 |
| Device Name: | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17405 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17405 |
| Product Code | DYH |
| Subsequent Product Code | EJF |
| Subsequent Product Code | NJM |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-07 |
| Decision Date | 2008-05-22 |
| Summary: | summary |