# K220077: IMICRYL Composite, Composite Flow Materials

- Pathway: 510(k) (Traditional)
- Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
- Decided: Aug 9, 2022 after 211 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: 2 generations back to K020342 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103190: Profil Composites (Profil, Profil Flow), Silmet, Ltd. (2011) Summary page 5.

## Indications for use
IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe) * Direct anterior & posterior restorations * Core Build Ups * Splinting IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza) * Class III, V & smaller Class IV restorations * Base/liner in Class I & Class II restorations * Repair resin, porcelain & acrylic temporary materials * Pit & fissure sealant * Undercut blockout * Restoration of minimally invasive cavity preparations

Source page: https://510kreport.com/device/K220077
Methodology: https://510kreport.com/methodology