The following data is part of a premarket notification filed by Dentmate Technology Co., Ltd. with the FDA for Ledex, Model: Wl-070.
| Device ID | K082408 |
| 510k Number | K082408 |
| Device Name: | LEDEX, MODEL: WL-070 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTMATE TECHNOLOGY CO., LTD. NO. 80-1, LANE 160, SEC. 4 SANHE ROAD Sanchung, TW 241 |
| Contact | Cheng-feng Chou |
| Correspondent | Cheng-feng Chou DENTMATE TECHNOLOGY CO., LTD. NO. 80-1, LANE 160, SEC. 4 SANHE ROAD Sanchung, TW 241 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-21 |
| Decision Date | 2008-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873920167 | K082408 | 000 |
| 04719873920150 | K082408 | 000 |
| 04719873920143 | K082408 | 000 |
| 04719873920136 | K082408 | 000 |
| 04719873920129 | K082408 | 000 |
| 04719873920112 | K082408 | 000 |
| 04719873920105 | K082408 | 000 |
| 04719873920099 | K082408 | 000 |
| 04719873920082 | K082408 | 000 |