The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Ideal 1 Orthodontic Band Cement.
| Device ID | K040375 |
| 510k Number | K040375 |
| Device Name: | IDEAL 1 ORTHODONTIC BAND CEMENT |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-04-02 |
| Summary: | summary |