# K083841: Adaptable Composite Resin Restorative Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Apr 14, 2009 after 111 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 K940459 (1994). 3 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981965: Flowable Composite, Dentsply Intl. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K041404: Clearblue Easy Easy Read Pregnancy Test, Unipath, Ltd. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K242713: Any-Com Bulk (2025), 0 descendants of its own

## Indications for use
Adaptable Composite Resin Restorative Material is indicated for the following procedures: 1. Indications with tooth/restorative interface * Class III and V restorations * Conservative Class I restorations * Small Class IV repairs * Tunnel Preparations * Filling of defects and undercuts in crown, inlay and onlay preparations * Blockouts * As a liner under direct restorative materials and under inlays restorations - Class II box liner * As a base or liner for cavity Class I and II restorations * Repair of small enamel defects * Covering incisal edge stains * Pit and fissure Sealant 2. Indications including tooth/indirect restorative materials * Cementing porcelain veneers, crowns, inlays/onlays * Intraoral porcelain repair 3. Amalgam margin repair 4. Provisional or Indirect Laboratory Indications: * Improving margins of acrylic temporaries * Provisional occlusal changes * Refacing acrylic temporaries * Margin correction/adjustment of composite crowns for indirect laboratory use

Source page: https://510kreport.com/device/K083841
Methodology: https://510kreport.com/methodology