The following data is part of a premarket notification filed by Bio Cetec Co., Ltd. with the FDA for S-line.
Device ID | K182193 |
510k Number | K182193 |
Device Name: | S-Line |
Classification | Bracket, Ceramic, Orthodontic |
Applicant | BIO CETEC CO., LTD. RM 1001-1002 New T Castle, 108, Gasan Digital 2-ro, Geumcheon-gu, Seoul, KR 08506 |
Contact | Hee See Jin |
Correspondent | Dave Kim MTECH GROUP 8310 Buffalo Speedway Houston, TX 77025 |
Product Code | NJM |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-14 |
Decision Date | 2019-01-22 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
S-LINE 88115910 5886727 Live/Registered |
Nikon Corporation 2018-09-13 |
S-LINE 79121202 4441823 Live/Registered |
Bircher Reglomat AG 2012-08-31 |
S-LINE 79089625 4011055 Live/Registered |
Volker Barkey 2010-07-14 |
S-LINE 77393870 3636238 Dead/Cancelled |
Integrated Illumination Systems Inc. 2008-02-11 |
S-LINE 76081919 2651127 Live/Registered |
OBCORP LLC 2000-06-30 |