The following data is part of a premarket notification filed by Discus Dental, Inc. with the FDA for Flash-lite Ii Led Dental Curing Light.
| Device ID | K023748 |
| 510k Number | K023748 |
| Device Name: | FLASH-LITE II LED DENTAL CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DISCUS DENTAL, INC. 8550 HIGUERA ST. Culver City, CA 90232 -2522 |
| Contact | Gary L Hollar |
| Correspondent | Gary L Hollar DISCUS DENTAL, INC. 8550 HIGUERA ST. Culver City, CA 90232 -2522 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-08 |
| Decision Date | 2003-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813CR1080R0 | K023748 | 000 |
| D813CR10800 | K023748 | 000 |
| D813CR10630 | K023748 | 000 |