The following data is part of a premarket notification filed by Dentsply International with the FDA for Cp Bracket System.
| Device ID | K052370 |
| 510k Number | K052370 |
| Device Name: | CP BRACKET SYSTEM |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | DENTSPLY INTERNATIONAL 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-30 |
| Decision Date | 2005-11-01 |
| Summary: | summary |