# K102803: Clarity Advanced Ceramic Brackets

- Pathway: 510(k) (Traditional)
- Applicant: 3M Unitek Corporation
- Decided: Feb 17, 2011 after 142 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: 3 generations back to K852179 (1985). 6 ancestors in all.
15 later devices descend from it; 7 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062345: Ceramic Bond, Voco GmbH (2006) Summary page 1.
- K944286: Metal-Lined Transcend Ceramic Bracket, Unitek Corp. (1994) Summary page 1.
- K950992: Ceramaflex Bracket System, Tp Orthodontics, Inc. (1995) Summary page 1.
- K082974: Mystique MB Ceramic Brackets, Dentsply Interntional (2008) Summary page 1.

## Most influential descendants
- K160615: Orthodontic Ceramic Brackets 1.1 (2016), 6 descendants of its own
- K181271: Signature Orthodontic System (2018), 4 descendants of its own
- K163467: C-Line Orthodontic Ceramic Bracket (2017), 2 descendants of its own
- K222764: LightForce Orthodontic System (2022), 1 descendant of its own
- K182193: S-Line (2019), 1 descendant of its own

## Indications for use
ClarityTm Advanced Ceramic Brackets 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/K102803
Methodology: https://510kreport.com/methodology