The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Lc Bracket Adhesive System.
| Device ID | K050750 |
| 510k Number | K050750 |
| Device Name: | LC BRACKET ADHESIVE SYSTEM |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-23 |
| Decision Date | 2005-04-06 |
| Summary: | summary |