The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Ideal 1 Orthodontic Bracket Adhesive.
| Device ID | K033703 |
| 510k Number | K033703 |
| Device Name: | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVENUE P.O. BOX 872 York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVENUE P.O. BOX 872 York, PA 17405 -0872 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-25 |
| Decision Date | 2004-02-06 |
| Summary: | summary |