The following data is part of a premarket notification filed by Dentmate Technology Co., Ltd. with the FDA for Ledex Wl070+.
| Device ID | K163605 |
| 510k Number | K163605 |
| Device Name: | LEDEX WL070+ |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTMATE TECHNOLOGY CO., LTD. 8F, No.8-11, Sec.1, Zhongxing Road, Wugu District New Taipei, TW 24872 |
| Contact | Cheng-feng Chou |
| Correspondent | Cheng-feng Chou DENTMATE TECHNOLOGY CO., LTD. 8F, No.8-11, Sec.1, Zhongxing Road, Wugu District New Taipei, TW 24872 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-21 |
| Decision Date | 2017-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873921966 | K163605 | 000 |
| 04719873921539 | K163605 | 000 |
| 04719873921263 | K163605 | 000 |
| 04719873920730 | K163605 | 000 |
| 04719873920723 | K163605 | 000 |
| 04719873920716 | K163605 | 000 |
| 04719873920709 | K163605 | 000 |
| 04719873920693 | K163605 | 000 |
| 04719873920686 | K163605 | 000 |
| 04719873921546 | K163605 | 000 |
| 04719873921553 | K163605 | 000 |
| 04719873921560 | K163605 | 000 |
| 04719873921959 | K163605 | 000 |
| 04719873921942 | K163605 | 000 |
| 04719873921935 | K163605 | 000 |
| 04719873921928 | K163605 | 000 |
| 04719873921911 | K163605 | 000 |
| 04719873921904 | K163605 | 000 |
| 04719873921584 | K163605 | 000 |
| 04719873921577 | K163605 | 000 |
| 04719873920679 | K163605 | 000 |