# K141994: Bulk Fill Flowable Composite

- Pathway: 510(k) (Traditional)
- Applicant: Novocol, Inc.
- Decided: Nov 14, 2014 after 115 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: 4 generations back to K940459 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091635: Venus Diamond Flow, Heraeus Kulzer, LLC (2009) Summary page 4.
- K120453: Filtek Bulk Fill Flowable Restorative, 3M Espe Dental Products (2012) Summary page 4.
- K123773: X-Tra Base, Voco GmbH (2012) Summary page 4.

## Indications for use
Base under Class I and II direct restorations Liner under direct restorative materials Class III and V restorations Undercut Blockout Minimally invasive cavities (including small non stress-bearing occlusal restorations) Tunnel preparations Repair of small enamel defects Repair of small defects in esthetic indirect restorations Repair of resin and acrylic temporary materials

Source page: https://510kreport.com/device/K141994
Methodology: https://510kreport.com/methodology