The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Tripton(tm) Visible Light-cured Univ. Bonding.
| Device ID | K885010 |
| 510k Number | K885010 |
| Device Name: | TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Contact | Demke, Dds |
| Correspondent | Demke, Dds COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-02 |
| Decision Date | 1989-02-13 |