The following data is part of a premarket notification filed by Flexodent Corp. with the FDA for Flexident Denture.
| Device ID | K760768 |
| 510k Number | K760768 |
| Device Name: | FLEXIDENT DENTURE |
| Classification | Denture Preformed (partially Prefabricated Denture) |
| Applicant | FLEXODENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKO |
| CFR Regulation Number | 872.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-04 |
| Decision Date | 1976-10-15 |