# K013571: Magicfil

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Jan 17, 2002 after 80 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 K924151 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924151: Bisco D/C Resinomer, Bisco, Inc. (1992) Summary page 1.
- K974577: Compoglass Flow, Ivoclar North America, Inc. (1998) Summary page 1.

## Indications for use
MagicFil is a dual cure compomer restorative material with additional colors and glitter for the restoration of deciduous teeth.

Source page: https://510kreport.com/device/K013571
Methodology: https://510kreport.com/methodology