The following data is part of a premarket notification filed by Bosworth Co. with the FDA for Denture Rubber Base Material.
| Device ID | K810094 |
| 510k Number | K810094 |
| Device Name: | DENTURE RUBBER BASE MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | BOSWORTH CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-14 |
| Decision Date | 1981-02-02 |