# K182580: Novidia Flowable Composite

- Pathway: 510(k) (Traditional)
- Applicant: Nobio, Ltd.
- Decided: Jul 3, 2019 after 287 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 K100235 (2010). 1 ancestor in all.
3 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)
- K100235: Filtek Supreme Ultra Flowable Restorative, 3M Company (2010) Summary page 4.

## Most influential descendants
- K182921: Infinix Universal Composite (2019), 2 descendants of its own
- K201010: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite (2020), 1 descendant of its own
- K253513: MultiMatch Flow Chameleon AntiMicrobial Composite (2025), 0 descendants of its own

## Indications for use
The Novidia™ Flowable Composite is indicated for: 1. Class III and V restorations 2. Restoration of minimally invasive cavity preparations (including small, non-stress bearing occlusal restorations) 3. As base/liner under direct or indirect restorations 4. Repair of small defects in esthetic indirect restorations 5. Pit and fissure sealing 6. Blocking out of undercuts 7. Repair of resin and acrylic temporary materials

Source page: https://510kreport.com/device/K182580
Methodology: https://510kreport.com/methodology