# K042178: Orthodontic Ceramic Brackets

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl.
- Decided: Aug 30, 2004 after 19 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: 1 generation back to K852179 (1985). 1 ancestor in all.
38 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852179: Ceramic Orthodonit Appliance, Gac Intl., Inc. (1985) Summary page 1.

## Most influential descendants
- K082974: Mystique MB Ceramic Brackets (2008), 23 descendants of its own
- K060837: IN-Ovation C (2006), 20 descendants of its own
- K102803: Clarity Advanced Ceramic Brackets (2011), 15 descendants of its own
- K123094: Orthodontic Ceramic Brackets (2012), 7 descendants of its own
- K160615: Orthodontic Ceramic Brackets 1.1 (2016), 6 descendants of its own

## Indications for use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Source page: https://510kreport.com/device/K042178
Methodology: https://510kreport.com/methodology