# K182921: Infinix Universal Composite

- Pathway: 510(k) (Traditional)
- Applicant: Nobio, Ltd.
- Decided: Sep 13, 2019 after 329 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: 2 generations back to K100235 (2010). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 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.
- K182580: Novidia Flowable Composite, Nobio, Ltd. (2019). Cleared while this submission was under review 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
The Infinix™ Universal Composite is indicated for: • 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

Source page: https://510kreport.com/device/K182921
Methodology: https://510kreport.com/methodology