Cleared Traditional

PIEZOMED

K133488 · W&H Dentalwerk Buermoos GmbH · Dental
Oct 2014
Decision
337d
Days
Class 2
Risk

About This 510(k) Submission

K133488 is an FDA 510(k) clearance for the PIEZOMED, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by W&H Dentalwerk Buermoos GmbH (Burmoos, AT). The FDA issued a Cleared decision on October 16, 2014, 337 days after receiving the submission on November 13, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K133488 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2013
Decision Date October 16, 2014
Days to Decision 337 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120