The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Composite 168 Restorative System.
| Device ID | K973221 |
| 510k Number | K973221 |
| Device Name: | COMPOSITE 168 RESTORATIVE SYSTEM |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-27 |
| Decision Date | 1998-02-09 |
| Summary: | summary |