The following data is part of a premarket notification filed by Dentsply International with the FDA for Sled Curing Light System.
| Device ID | K031615 |
| 510k Number | K031615 |
| Device Name: | SLED CURING LIGHT SYSTEM |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTERNATIONAL 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-23 |
| Decision Date | 2003-07-21 |
| Summary: | summary |