The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for One Coat Se Bond.
| Device ID | K033760 |
| 510k Number | K033760 |
| Device Name: | ONE COAT SE BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | COLTENE/WHALEDENT INC. 1349 LEXINGTON AVE. New York, NY 10128 |
| Contact | Henry J Vogelstein |
| Correspondent | Henry J Vogelstein COLTENE/WHALEDENT INC. 1349 LEXINGTON AVE. New York, NY 10128 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-02 |
| Decision Date | 2004-01-23 |