# K981965: Flowable Composite

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jul 10, 1998 after 36 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K940459 (1994). 2 ancestors in all.
11 later devices descend from it; 2 cite 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)
- K940459: Multipurpose Resin Cement with Fluoride (MRCF), Dentsply Intl. (1994) Summary page 1.
- K955292: Aeliteflo, Bisco, Inc. (1995) Summary page 1.

## Most influential descendants
- K083841: Adaptable Composite Resin Restorative Material (2009), 9 descendants of its own
- K120453: Filtek Bulk Fill Flowable Restorative (2012), 8 descendants of its own
- K182714: Novidia Bulk Fill Flow 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
Filling of defects and undercuts in crowns, inlays and onlays; Liner under direct restorative materials and under inlay restorations—Class II box liner; Tunnel preparations; Pit and fissure sealants; Amalgam margin repair; Improving margins of acrylic temporaries; Small class IV repairs; Intraoral porcelain repair; Cementing porcelain veneers, crowns, inlays/onlays; Refacing acrylic temporaries; Blockouts; Covering incisal edge stains; Repair of small enamel defects; Provisional occlusal changes; Class III, V restorations; Conservative Class I restorations; Margin correction/adjustment of composite crowns for indirect laboratory use

Source page: https://510kreport.com/device/K981965
Methodology: https://510kreport.com/methodology