The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Denture Reline Material.
| Device ID | K780786 |
| 510k Number | K780786 |
| Device Name: | DENTURE RELINE MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTL. 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 | 1978-05-12 |
| Decision Date | 1978-06-14 |