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 |