# K210349: TKO Composite Bite Turbo Gel

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Orthodontic Products, Inc.
- Decided: Jul 20, 2021 after 162 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K880393 (1988). 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)
- K192682: Orthocem, Ortho Bite, Dentscare Ltda (2020) Summary page 4.

## Indications for use
TKO is a pink, flowable light cure composite gel for the creation of occlusal buildups (bite turbos) and as a retainer repair composite.

Source page: https://510kreport.com/device/K210349
Methodology: https://510kreport.com/methodology