The following data is part of a premarket notification filed by Dentsply International with the FDA for Smartlite Ps Pen-style Led Curing Light.
| Device ID | K041372 |
| 510k Number | K041372 |
| Device Name: | SMARTLITE PS PEN-STYLE LED CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTSPLY INTERNATIONAL 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTERNATIONAL 221 WEST PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-24 |
| Decision Date | 2004-06-24 |
| Summary: | summary |