# K103190: Profil Composites (Profil, Profil Flow)

- Pathway: 510(k) (Traditional)
- Applicant: Silmet, Ltd.
- Decided: Feb 2, 2011 after 97 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 K020342 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051867: Grandio, Voco GmbH (2005) Summary page 4.
- K020342: Unifil Flow, GC America, Inc. (2002) Summary page 1.
- K100235: Filtek Supreme Ultra Flowable Restorative, 3M Company (2010) Summary page 1.

## Most influential descendants
- K220077: IMICRYL Composite, Composite Flow Materials (2022), 0 descendants of its own

## Indications for use
ProFil Direct anterior & posterior restorations Core Build ups Splinting ProFil Flow Class 111, V & smaller Class IV restorations Base/liner in Class I & Class 11 restorations Repair resin, porcelain & acrylic temporary materials Pit & fissure sealant Undercut blockout Restoration of minimally invasive cavity preparations

Source page: https://510kreport.com/device/K103190
Methodology: https://510kreport.com/methodology