# K182193: S-Line

- Pathway: 510(k) (Traditional)
- Applicant: Biocetec Co., Ltd.
- Decided: Jan 22, 2019 after 161 days
- Product code: NJM (Bracket, Ceramic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K852179 (1985). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163467: C-Line Orthodontic Ceramic Bracket, Biocetec Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K231635: A-Line Advanced (2023), 0 descendants of its own

## Indications for use
S-LineTM orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position

Source page: https://510kreport.com/device/K182193
Methodology: https://510kreport.com/methodology