# K131197: Edgewise Ceramic Brackets, Roth Ceramic Brackets

- Pathway: 510(k) (Traditional)
- Applicant: Dental Morelli
- Decided: Aug 27, 2013 after 123 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 1.

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

Source page: https://510kreport.com/device/K131197
Methodology: https://510kreport.com/methodology