# K160957: CDB Self Ligating Bracket 8F

- Pathway: 510(k) (Traditional)
- Applicant: Cdb Corporation
- Decided: Sep 27, 2016 after 175 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)
- K060837: IN-Ovation C, Dentsply International (2006) Summary page 4.
- K111234: Click-IT, Tp Orthodontics, Inc. (2011) Summary page 7.
- K062345: Ceramic Bond, Voco GmbH (2006) Summary page 7.

## Indications for use
The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid.

Source page: https://510kreport.com/device/K160957
Methodology: https://510kreport.com/methodology