The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for R-30 Aesthetic Restorative.
| Device ID | K984387 |
| 510k Number | K984387 |
| Device Name: | R-30 AESTHETIC RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-08 |
| Decision Date | 1999-01-13 |
| Summary: | summary |