The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Trubyte Soft Reline System.
| Device ID | K964040 |
| 510k Number | K964040 |
| Device Name: | TRUBYTE SOFT RELINE SYSTEM |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTL. 500 WEST COLLEGE AVE. York, PA 17405 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 500 WEST COLLEGE AVE. 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 | 1996-10-08 |
| Decision Date | 1996-12-06 |
| Summary: | summary |