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 |