# K120453: Filtek Bulk Fill Flowable Restorative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: Mar 19, 2012 after 34 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: 3 generations back to K940459 (1994). 7 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100235: Filtek Supreme Ultra Flowable Restorative, 3M Company (2010) Summary page 1.
- K083841: Adaptable Composite Resin Restorative Material, Dentsply International, Inc. (2009) Summary page 1.
- K013647: Revolution Formula 2, Sybron Dental Specialties, Inc. (2002) Summary page 1.
- K981647: 3M Dent II System, 3M Company (1998) Summary page 1.

## Most influential descendants
- 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
- K242014: Jet Flow Bulk (2024), 0 descendants of its own

## Indications for use
*Base under Class I and 11 direct restorations *Liner under direct restorative materials *Pit and fissure sealant *Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations) *Class III and V restorations *Undercut blockout *Repair of small enamel defects Repair of small defects in esthetic indirect restorations *Repair of resin and acrylic temporary materials *As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

Source page: https://510kreport.com/device/K120453
Methodology: https://510kreport.com/methodology