The following data is part of a premarket notification filed by Diadent Group International with the FDA for D-lux.
Device ID | K130163 |
510k Number | K130163 |
Device Name: | D-LUX |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | DIADENT GROUP INTERNATIONAL 626, YEONJE-RI, GANGOE-MYEON CHEONGWON-GUN Chungcheong Buk-do, KR 363-951 |
Contact | Gil Jun, Hong |
Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-01-23 |
Decision Date | 2013-08-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08806383552868 | K130163 | 000 |
08806383540933 | K130163 | 000 |
08806383540926 | K130163 | 000 |
08806383540919 | K130163 | 000 |
08806383540902 | K130163 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
D-LUX 79132487 4733593 Live/Registered |
Leica Camera AG 2013-07-10 |
D-LUX 78084228 not registered Dead/Abandoned |
Random Distributions, LLC 2001-09-17 |
D-LUX 78062747 not registered Dead/Abandoned |
USA Sports, Inc. 2001-05-09 |
D-LUX 77744284 3728066 Live/Registered |
Brian Brothers, Inc. 2009-05-26 |
D-LUX 77528455 not registered Dead/Abandoned |
Henkel AG & Co. KGaA 2008-07-22 |
D-LUX 76529141 2881026 Live/Registered |
Leica Camera AG 2003-07-10 |
D-LUX 74218000 1767103 Dead/Cancelled |
FURUKAWA ELECTRIC NORTH AMERICA, INC. 1991-10-29 |