# K110335: Ceramic Brackets

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Organizers, Inc.
- Decided: May 19, 2011 after 104 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: 1 generation back to K861965 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861965: Unitek Ceramic Bracket System, Unitek Corp. (1986) Summary page 2.
- K944286: Metal-Lined Transcend Ceramic Bracket, Unitek Corp. (1994) Summary page 3.
- K062305: Clarity Modified Ceramic Brackets, 3M Unitek (2006) Summary page 3.

## Indications for use
These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have inierface with the ardhwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.

Source page: https://510kreport.com/device/K110335
Methodology: https://510kreport.com/methodology