# K123092: Ceramin Brackets Z

- Pathway: 510(k) (Traditional)
- Applicant: Tomy, Inc.
- Decided: Dec 21, 2012 after 80 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 1.
- K060837: IN-Ovation C, Dentsply International (2006) Summary page 1.

## Indications for use
CERAMIC BRACKETS Z are indicated for orthodontic movement on natural teeth surfaces.

Source page: https://510kreport.com/device/K123092
Methodology: https://510kreport.com/methodology