# K852179: Ceramic Orthodonit Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Gac Intl., Inc.
- Decided: Aug 20, 1985 after 92 days
- Product code: EJF (Bracket, Metal, Orthodontic)
- Device class: 1
- Regulation: 21 CFR 872.5410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 2 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042178: Orthodontic Ceramic Brackets (2004), 38 descendants of its own
- 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

Source page: https://510kreport.com/device/K852179
Methodology: https://510kreport.com/methodology