The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Trubyte Denture Base Resin System.
| Device ID | K011560 |
| 510k Number | K011560 |
| Device Name: | TRUBYTE DENTURE BASE RESIN SYSTEM |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-21 |
| Decision Date | 2001-07-12 |