# K123348: Clear Aligner Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Orthodontic Products, Inc.
- Decided: Feb 28, 2013 after 120 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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 CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.

Source page: https://510kreport.com/device/K123348
Methodology: https://510kreport.com/methodology