# K201707: Opallis, Opallis Flow

- Pathway: 510(k) (Traditional)
- Applicant: Dentscare Ltda
- Decided: Dec 22, 2020 after 183 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 K993783 (1999). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K042819: Tetric Evoceram, Ivoclar Vivadent, Inc. (2004) Summary page 4.
- K993783: Tetric Flow, Ivoclar North America, Inc. (1999) Summary page 4.

## Most influential descendants
- K232994: Vittra APS Unique Flow (2024), 0 descendants of its own
- K231263: Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (2024), 0 descendants of its own

## Indications for use
Opallis (Sculptable version) The composite is suitable for use in permanent and deciduous teeth: - Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI. - Direct veneers with composites. - Cementation of tooth fragments. - Core build-ups. - Teeth splinting. - Diastema closing or reduction. - Modification of teeth's shape (e.g.: conoid teeth). - Porcelain/composite repairs. Opallis Flow (Flowable version) - Base/lining underneath direct restorations. - Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy - Pit and fissure sealant. - Tunnel-type preparation. - Repair of enamel defects. - Bonding of tooth fragments. - Repairs in composite resin. - Non-carious cervical lesions. - Planning of preparation walls.

Source page: https://510kreport.com/device/K201707
Methodology: https://510kreport.com/methodology