The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Sureflex Files.
| Device ID | K951607 |
| 510k Number | K951607 |
| Device Name: | SUREFLEX FILES |
| Classification | Burnisher, Operative |
| Applicant | DENTSPLY INTL. 500 WEST COLLEGE AVE. York, PA 17404 |
| Contact | P. J Lehn |
| Correspondent | P. J Lehn DENTSPLY INTL. 500 WEST COLLEGE AVE. York, PA 17404 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-16 |
| Decision Date | 1995-06-22 |