# K251283: Once-Fil Flow

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Jun 6, 2025 after 42 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 K153493 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153493: Clip Flow, Voco GmbH (2016) Summary page 5.

## Indications for use
- Temporary inlay and onlay treatments of the cavity. - Sealing of openings for implant screws. - Relining material for temporary crowns and bridges. - Covering of the gingival margin - Fixing of resin matrix during filling placement. - Block-out material for retentive ares in the dental arch, e.g. before taking impressions.

Source page: https://510kreport.com/device/K251283
Methodology: https://510kreport.com/methodology