Cleared Traditional

Advanced Air System

K143704 · W&H Dentalwerk Buermoos GmbH · Dental
Nov 2015
Decision
329d
Days
Class 1
Risk

About This 510(k) Submission

K143704 is an FDA 510(k) clearance for the Advanced Air System, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by W&H Dentalwerk Buermoos GmbH (Burmoos, AT). The FDA issued a Cleared decision on November 23, 2015, 329 days after receiving the submission on December 29, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K143704 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2014
Decision Date November 23, 2015
Days to Decision 329 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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