The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Coltene A.r.t. Bond.
| Device ID | K922615 |
| 510k Number | K922615 |
| Device Name: | COLTENE A.R.T. BOND |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | COLTENE/WHALEDENT INC. 236 FIRTH AVE. New York, NY 10001 |
| Contact | Vogelstein |
| Correspondent | Vogelstein COLTENE/WHALEDENT INC. 236 FIRTH AVE. New York, NY 10001 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-02 |
| Decision Date | 1992-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00673690 | K922615 | 000 |
| J00673640 | K922615 | 000 |
| J00673630 | K922615 | 000 |
| J00673620 | K922615 | 000 |