# K160615: Orthodontic Ceramic Brackets 1.1

- Pathway: 510(k) (Traditional)
- Applicant: Tomy, Inc.
- Decided: Aug 26, 2016 after 176 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: 4 generations back to K852179 (1985). 9 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102803: Clarity Advanced Ceramic Brackets, 3M Unitek Corporation (2011) Summary page 4.
- K123094: Orthodontic Ceramic Brackets, Tomy, Inc. (2012) Summary page 4.

## Most influential descendants
- K181271: Signature Orthodontic System (2018), 4 descendants of its own
- K222764: LightForce Orthodontic System (2022), 1 descendant of its own
- K183542: Signature Orthodontic System (2019), 1 descendant of its own
- K232827: LightForce Orthodontic System (2023), 0 descendants of its own
- K200148: LightForce Orthodontic System (LFO System) (2020), 0 descendants of its own

## Indications for use
ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.

Source page: https://510kreport.com/device/K160615
Methodology: https://510kreport.com/methodology