# K143209: SonicFill 2

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties
- Decided: Feb 5, 2015 after 87 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: 1 generation back to K091023 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091023: Metamorphosis, Kerr Corporation (2009) Summary page 4.

## Indications for use
SonicFill 2 is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core build-ups and incisal abrasions.

Source page: https://510kreport.com/device/K143209
Methodology: https://510kreport.com/methodology
