# K051933: Expasyl Power Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jan 3, 2006 after 174 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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 FDA summary names its predicate without a number.
- (no number) Electro Medical Systems, EMS Air-Flow handy 2: named in the summary without a submission number

## Indications for use
The Expasyl Power Applicator is a dental handpiece intended to be used to dispense Expasyl, a hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator.

Source page: https://510kreport.com/device/K051933
Methodology: https://510kreport.com/methodology