The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for One Coat Bond Dentin/enamel Adhesive System.
| Device ID | K974906 |
| 510k Number | K974906 |
| Device Name: | ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-31 |
| Decision Date | 1998-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00656410 | K974906 | 000 |
| J00656400 | K974906 | 000 |
| J00676300 | K974906 | 000 |
| J00678790 | K974906 | 000 |
| J00678730 | K974906 | 000 |
| J00676360 | K974906 | 000 |
| J00676350 | K974906 | 000 |
| J00674300 | K974906 | 000 |
| J006600117570 | K974906 | 000 |