# K950992: Ceramaflex Bracket System

- Pathway: 510(k) (Traditional)
- Applicant: Tp Orthodontics, Inc.
- Decided: May 3, 1995 after 61 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
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K102803: Clarity Advanced Ceramic Brackets (2011), 15 descendants of its own
- 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

Source page: https://510kreport.com/device/K950992
Methodology: https://510kreport.com/methodology