The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Dual Cure Reline Material.
| Device ID | K926406 |
| 510k Number | K926406 |
| Device Name: | DUAL CURE RELINE MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | Jeffery Lehn |
| Correspondent | Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1993-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0019055370 | K926406 | 000 |