Cleared Traditional

AMADEO, M-UK1015 (incl. attachments and accessories)

K213221 · W&H Dentalwerk Buermoss GmbH · Dental

May 2022

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K213221 is an FDA 510(k) clearance for the AMADEO, M-UK1015 (incl. attachments and accessories), a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by W&H Dentalwerk Buermoss GmbH (Burmoos, AT). The FDA issued a Cleared decision on May 26, 2022, 239 days after receiving the submission on September 29, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K213221 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2021
Decision Date	May 26, 2022
Days to Decision	239 days
Submission Type	Traditional
Review Panel	Dental (DE)
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