The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Trubyte Denture Cleanser/polishing Compound.
| Device ID | K000996 |
| 510k Number | K000996 |
| Device Name: | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND |
| Classification | Cleanser, Denture, Over The Counter |
| 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 | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-28 |
| Decision Date | 2000-06-16 |