# K141104: Truklear Bracket

- Pathway: 510(k) (Special)
- Applicant: Ajw Technology Consultants, Inc.
- Decided: Jun 25, 2014 after 57 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090933: Bernhard-Forster GMBH Orthodontic Ceramic Brackets, Forestadent Bernhard Forster GmbH (2009) Summary page 2.

## Indications for use
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended for single use only.

Source page: https://510kreport.com/device/K141104
Methodology: https://510kreport.com/methodology