LEDEX
Activator, Ultraviolet, For Polymerization
Dentmate Technology Co. Ltd.
The following data is part of a premarket notification filed by Dentmate Technology Co. Ltd. with the FDA for Ledex.
Pre-market Notification Details
| Device ID | K221194 |
| 510k Number | K221194 |
| Device Name: | LEDEX |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-09-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873922444 | K221194 | 000 |
| 04719873922215 | K221194 | 000 |
Trademark Results [LEDEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEDEX 79053189 3623155 Dead/Cancelled |
Johnson Electric Holdings Limited 2007-09-12 |
 LEDEX 77472235 3605294 Live/Registered |
SAIA-BURGESS LLC 2008-05-12 |
 LEDEX 76482401 2797199 Live/Registered |
ADEPCO TECHNOLOGIES CORPORATION 2003-01-13 |
 LEDEX 76147815 3182151 Dead/Cancelled |
TSCI LLC 2000-10-16 |
 LEDEX 75845161 2868204 Dead/Cancelled |
LED EXPERT CORPORATION 1999-11-30 |
 LEDEX 73069113 1046280 Dead/Expired |
LEDEX, INC. 1975-11-14 |
 LEDEX 71542853 0504841 Dead/Expired |
G. H. LELAND, INC. 1947-12-01 |
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