# K242179: Synea Fusion Handpieces (Intensiv & Profin)

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Bürmoos GmbH
- Decided: Feb 28, 2025 after 218 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K082827 (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)
- K082827: A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece Attachment, A-Dec, Inc. (2009) Summary page 5.

## Indications for use
The reciprocating/oscillating contra-angle handpieces are for the following applications: Preparation, removing protrusions or excess of filling materials and cements, finishing and polishing in the interdental, supragingival and subgingival regions, plaque removal and IPR (interproximal reduction) in orthodontics.

Source page: https://510kreport.com/device/K242179
Methodology: https://510kreport.com/methodology