K243280
- 510(k) number
- K243280
- Device name
- Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
- Applicant
- W&H Dentalwerk Buermoos GmbH AT
- Product code
- ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Includi
- Decision date
- 2025-07-03
- Date received
- 2024-10-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243280.pdf
Official FDA record: K243280
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.