# K130237: Pontic Paint

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Orthodontic Products, Inc.
- Decided: Apr 5, 2013 after 64 days
- Product code: NXC (Aligner, Sequential)
- 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: 2 generations back to K030951 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083051: Flowtain & Flowtain LV, Reliance Orthodontic Products, Inc. (2009) Summary page 1.
- K880792: Plastic Primer, Reliance Orthodontic Products, Inc. (1988) Summary page 1.

## Indications for use
The Pontic Paint is intended for use as a light cure coloring agent of thermtoplastic aligners.

Source page: https://510kreport.com/device/K130237
Methodology: https://510kreport.com/methodology