The following data is part of a premarket notification filed by Mectron S.p.a. with the FDA for Starlight Pro And Siliverlight Dental Curing Lights.
| Device ID | K092951 |
| 510k Number | K092951 |
| Device Name: | STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | MECTRON S.P.A. 15, VIA LORETO Carasco, IT 16042 |
| Contact | Roger Gray |
| Correspondent | Roger Gray MECTRON S.P.A. 15, VIA LORETO Carasco, IT 16042 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-24 |
| Decision Date | 2009-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E322051001000020 | K092951 | 000 |