# K182714: Novidia Bulk Fill Flow Composite

- Pathway: 510(k) (Traditional)
- Applicant: Nobio, Ltd.
- Decided: Jul 12, 2019 after 288 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: 4 generations back to K940459 (1994). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120453: Filtek Bulk Fill Flowable Restorative, 3M Espe Dental Products (2012) Summary page 4.

## Most influential descendants
- 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
Novidia™ Bulk Fill Flow Composite is indicated for: 1. Base under Class I and II direct restorations 2. Liner under direct restorative materials 3. Pit and fissure sealant 4. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations) 5. Class III and V restorations 6. Blocking out of undercuts 7. Repair of small enamel defects 8. Repair of small defects in esthetic indirect restorations 9. Repair of resin and acrylic temporary materials 10. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

Source page: https://510kreport.com/device/K182714
Methodology: https://510kreport.com/methodology