# K083051: Flowtain & Flowtain LV

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Orthodontic Products, Inc.
- Decided: Feb 20, 2009 after 129 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: 1 generation back to K030951 (2003). 2 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073697: Transbond Supreme Adhesive, 3M Unitek (2008) Summary page 2.
- K030951: Tesceraflo A2, Model T-21012P; Tesceraflo A2 Opaque, Model T-210120P, Bisco, Inc. (2003) Summary page 2.

## Most influential descendants
- K234043: 3M™ Transbond™ Orthodontic Adhesive (2023), 0 descendants of its own
- K130237: Pontic Paint (2013), 0 descendants of its own
- K123348: Clear Aligner Adhesive (2013), 0 descendants of its own
- K101951: Light Cure Retainer (2010), 0 descendants of its own
- K100301: Opal Bond Flow (2010), 0 descendants of its own

## Indications for use
FlowtainTM is a flowable, light-cure orthodontic adhesive intended, to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers and splinting materials, creation of archwire stops and indirect bonding of orthodontic brackets. FlowtainTM can also be used for the retention of thermoplastic aligners. FlowtainTm LV is a lower viscosity, flowable light cure orthodontic adhesive intended to be used for indirect bonding of orthodontic brackets.

Source page: https://510kreport.com/device/K083051
Methodology: https://510kreport.com/methodology