Cleared Traditional

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

K243280 · W&H Dentalwerk Buermoos GmbH · Ear, Nose, Throat

Jul 2025

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K243280 is an FDA 510(k) clearance for the Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories), a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on July 3, 2025, 259 days after receiving the submission on October 17, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K243280 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2024
Decision Date	July 03, 2025
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4250