# K013400: Synergy Flow

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Dec 10, 2001 after 56 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Class V fillings Class III, IV fillings in anterior teeth Small fillings in posterior teeth Fillings of minimal cavities Repair of composite and ceramic veneers Blocking out undercuts Cementing of composite and ceramic restorations

Source page: https://510kreport.com/device/K013400
Methodology: https://510kreport.com/methodology