# K253513: MultiMatch Flow Chameleon AntiMicrobial Composite

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Company
- Decided: Nov 7, 2025 after 1 day
- 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: 6 generations back to K940459 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201010: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite, Nobio, Ltd. (2020) Summary page 5.

## Indications for use
Direct restorations in all cavity classes (I-V) Base / liner under direct restoration Veneering of discolored anterior teeth Splinting of mobile teeth Extended pit and fissure sealing in molars and premolars Repair of composite/ceramic veneers Retention of thermoplastic aligners The addition of anti-microbial particles to MultiMatch Flow Chameleon AntiMicrobial Composite reduces demineralization and the total amount of bacteria at the material surface, which is part of the caries-formation process.

Source page: https://510kreport.com/device/K253513
Methodology: https://510kreport.com/methodology