The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Opalux Visible Light Cured Anterior Composite.
| Device ID | K863882 |
| 510k Number | K863882 |
| Device Name: | OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Contact | Sharma, Ph.d. |
| Correspondent | Sharma, Ph.d. COE LABORATORIES, INC. 3737 W. 127TH ST. Alsip, IL 60658 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-06 |
| Decision Date | 1986-11-18 |