# K231635: A-Line Advanced

- Pathway: 510(k) (Traditional)
- Applicant: Biocetec Co., Ltd.
- Decided: Jun 6, 2023 after 1 day
- 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: 6 generations back to K852179 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182193: S-Line, Biocetec Co., Ltd. (2019) Summary page 4.

## Indications for use
A-Line Advanced 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/K231635
Methodology: https://510kreport.com/methodology