# K210115: FiteBac CC OrthoSeal

- Pathway: 510(k) (Traditional)
- Applicant: Largent Health, LLC
- Decided: Jul 29, 2021 after 191 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 K023042 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090355: Opal Seal, Ultradent Products, Inc. (2009) Summary page 5.
- K880393: Transbond Light Cured Orthodontic Adhesive, Unitek Corp. (1988) Summary page 5.

## Indications for use
FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.

Source page: https://510kreport.com/device/K210115
Methodology: https://510kreport.com/methodology