# K180404: 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Mar 16, 2018 after 30 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
3M™ Clarity™ Ultra Brackets and Adhesive Coated Appliance System 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/K180404
Methodology: https://510kreport.com/methodology