# K222847: Ceramic Brackets Orthometric

- Pathway: 510(k) (Traditional)
- Applicant: Orthometric - Industria E Comercio DE Produtos Medicos
- Decided: May 4, 2023 after 225 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

Source page: https://510kreport.com/device/K222847
Methodology: https://510kreport.com/methodology