# K973976: Epic-Flo

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Dec 4, 1997 after 45 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. The FDA summary names its predicate without a number.
- (no number) Zenith Flowable Composite: named in the summary without a submission number
- (no number) Centrix Flo-Fil: named in the summary without a submission number
- (no number) Aeliteflo: named in the summary without a submission number
- (no number) Ultradent Flowable Composite: named in the summary without a submission number
- (no number) Comp=Flow: named in the summary without a submission number

## Indications for use
A light-cured, flowable composite, for use as a tooth restorative in all class cavities (I, II, III, IV and V). It is especially suitable for use in non-stress bearing class I and III restorations and for class V lesions. It may be used as a liner in all class cavity preparations, and as a pit and fissure sealant or as a composite luting resin. The material is well-suited as an undercut block-out material in cavity preparations. It may be used with all currently available dentin bonding systems.

Source page: https://510kreport.com/device/K973976
Methodology: https://510kreport.com/methodology