The following data is part of a premarket notification filed by Dxm Co., Ltd. with the FDA for Cybird Led Curing Light.
| Device ID | K042703 |
| 510k Number | K042703 |
| Device Name: | CYBIRD LED CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DXM CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-10-12 |
| Summary: | summary |