The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Occlu-seal(tm) Visible Light-cured Fissure Sealant.
| Device ID | K891140 |
| 510k Number | K891140 |
| Device Name: | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-05-01 |