# K123094: Orthodontic Ceramic Brackets

- Pathway: 510(k) (Traditional)
- Applicant: Tomy, Inc.
- Decided: Dec 13, 2012 after 72 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: 3 generations back to K852179 (1985). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060837: IN-Ovation C, Dentsply International (2006) Summary page 1.
- K082974: Mystique MB Ceramic Brackets, Dentsply Interntional (2008) Summary page 1.

## Most influential descendants
- K160615: Orthodontic Ceramic Brackets 1.1 (2016), 6 descendants of its own
- 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

## Indications for use
Orthodontic Ceramic Brackets are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Source page: https://510kreport.com/device/K123094
Methodology: https://510kreport.com/methodology