The following data is part of a premarket notification filed by Dentmate Technology Co., Ltd. with the FDA for Ledex.
Device ID | K131042 |
510k Number | K131042 |
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 City, 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 City, TW 24872 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-15 |
Decision Date | 2013-10-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07908611204455 | K131042 | 000 |
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 |