# K974577: Compoglass Flow

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Jan 30, 1998 after 53 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K013571: Magicfil (2002), 0 descendants of its own

## Indications for use
Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects) Restorations in deciduous teeth Intermediary restorations Anterior Class III restorations

Source page: https://510kreport.com/device/K974577
Methodology: https://510kreport.com/methodology