# K091091: Sonicfill 2010

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Oct 14, 2009 after 181 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K051933: Expasyl Power Applicator, Sybron Dental Specialties, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The SONICFill 2010 is a dental delivery system intended to be used to dispense Metamorphosis, a dental restorative resin, directly into dental cavities.

Source page: https://510kreport.com/device/K091091
Methodology: https://510kreport.com/methodology