FDA 510(k) clearance · back to tracker

Synea Fusion Handpieces (Intensiv & Profin)

W&H Dentalwerk Bürmoos GmbH cleared K242179 on 2025-02-28, decision: substantially equivalent

K-number

K242179

Sponsor

W&H Dentalwerk Bürmoos GmbH

Device

Synea Fusion Handpieces (Intensiv & Profin)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-02-28

Product code

EFB

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.4200

Official FDA record

Open K242179on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K242179 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.