The following data is part of a premarket notification filed by Coe Laboratories, Inc. with the FDA for Self-curing Hard Denture Liner.
| Device ID | K820673 |
| 510k Number | K820673 |
| Device Name: | SELF-CURING HARD DENTURE LINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | COE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-11 |
| Decision Date | 1982-04-09 |