The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Superline.
Device ID | K213599 |
510k Number | K213599 |
Device Name: | SuperLine |
Classification | Implant, Endosseous, Root-form |
Applicant | Dentium Co., Ltd. 76, Changnyong-daero 256beon-gil Suwon-si, KR 16229 |
Contact | Eunsang Lee |
Correspondent | Kevin A Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-15 |
Decision Date | 2022-02-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUPERLINE 98512005 not registered Live/Pending |
Lee, Eric 2024-04-22 |
SUPERLINE 98041067 not registered Live/Pending |
Akwue, Donald 2023-06-13 |
SUPERLINE 88387440 not registered Live/Pending |
British American Tobacco (Brands) Limited 2019-04-16 |
SUPERLINE 85057347 3907866 Live/Registered |
Superline, Inc. 2010-06-08 |
SUPERLINE 77699562 3847011 Live/Registered |
Dentium Co. Ltd. 2009-03-26 |
SUPERLINE 77451339 3536873 Live/Registered |
Master-Pull, LLC 2008-04-17 |
SUPERLINE 75943018 2433520 Dead/Cancelled |
Superline Inc. 2000-03-13 |
SUPERLINE 75432544 2525420 Dead/Cancelled |
AG Communication Systems Corporation 1998-02-11 |
SUPERLINE 75213379 2138554 Live/Registered |
MVP (H.K.) Industries Ltd. 1996-12-16 |
SUPERLINE 75210312 2140436 Live/Registered |
MVP (H.K.) Industries Ltd. 1996-12-09 |
SUPERLINE 74589299 1946566 Dead/Cancelled |
BEAUTONE SPECIALTIES CO., LTD. 1994-10-24 |
SUPERLINE 74313129 1857931 Dead/Cancelled |
US Wats, Inc. 1992-09-11 |