# K201010: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite

- Pathway: 510(k) (Traditional)
- Applicant: Nobio, Ltd.
- Decided: Aug 14, 2020 after 119 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: 5 generations back to K940459 (1994). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182921: Infinix Universal Composite, Nobio, Ltd. (2019) Summary page 6.
- K182580: Novidia Flowable Composite, Nobio, Ltd. (2019) Summary page 7.
- K182714: Novidia Bulk Fill Flow Composite, Nobio, Ltd. (2019) Summary page 7.

## Most influential descendants
- K253513: MultiMatch Flow Chameleon AntiMicrobial Composite (2025), 0 descendants of its own

## Indications for use
Restorations in the posterior region (Class I and II) Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Veneering of discolored anterior teeth Splinting of mobile teeth Extended fissure sealing in molars and premolars Repair of composite/ceramic veneers The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process. Class III and V restorations Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations) As base/liner under direct or indirect restorations Repair of small defects in aesthetic indirect restorations Pit and fissure sealant Blocking out of undercuts Repair of resin and acrylic temporary materials The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process. Base under Class I and II direct restorations Liner under direct restorative materials Pit and fissure sealant Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations) Class III and V restorations Blocking out of undercuts Repair of small enamel defects Repair of small defects in esthetic indirect restorations Repair of resin and acrylic temporary materials As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown The addition of the QASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.

Source page: https://510kreport.com/device/K201010
Methodology: https://510kreport.com/methodology