The following data is part of a premarket notification filed by Coltene Ag with the FDA for Cool Bond Light Cured Bracket Adhesive System.
| Device ID | K022224 |
| 510k Number | K022224 |
| Device Name: | COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | COLTENE AG 750 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE AG 750 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-10 |
| Decision Date | 2002-09-18 |