The following data is part of a premarket notification filed by Diadent Group International with the FDA for D-lux+.
| Device ID | K200809 |
| 510k Number | K200809 |
| Device Name: | D-LUX+ |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, KR 28161 |
| Contact | Kab Sun Lee |
| Correspondent | Kab Sun Lee Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, KR 28161 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-27 |
| Decision Date | 2020-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806383580939 | K200809 | 000 |
| 08806383568777 | K200809 | 000 |
| 08806383568784 | K200809 | 000 |
| 08806383568791 | K200809 | 000 |
| 08806383568807 | K200809 | 000 |
| 08806383568814 | K200809 | 000 |
| 08806383568821 | K200809 | 000 |
| 08806383568838 | K200809 | 000 |
| 08806383568845 | K200809 | 000 |
| 08806383568760 | K200809 | 000 |