# K020760: Starflow HV

- Pathway: 510(k) (Traditional)
- Applicant: Danville Materials, Inc.
- Decided: May 3, 2002 after 57 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: 1 generation back to K990108 (1999). 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)
- K013647: Revolution Formula 2, Sybron Dental Specialties, Inc. (2002) Summary page 1.
- K990108: LC Flowfill, S & C Polymer GmbH (1999) Summary page 1.
- K993783: Tetric Flow, Ivoclar North America, Inc. (1999) Summary page 1.

## Indications for use
Starflow HV is intended for use for the restoration of Class III, Class IV, and Class V cavities, small Class I cavities not in occlusion, repair of enamel defects, repair of porcelain restorations, minor occusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for seramic/composite veneers, incisal abrasions, and core build-ups.

Source page: https://510kreport.com/device/K020760
Methodology: https://510kreport.com/methodology