The following data is part of a premarket notification filed by Dxm Co., Ltd. with the FDA for D1 Led Curing Light, Spec 3, Dentronix Led 3000.
| Device ID | K121093 |
| 510k Number | K121093 |
| Device Name: | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DXM CO., LTD. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah DXM CO., LTD. 55 NORTHERN BLVD. Great Neck, NY 11021 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-10 |
| Decision Date | 2012-11-27 |
| Summary: | summary |