Cleared Traditional

W&H HANDPIECE ANESTO, MODEL: RA-5

K083811 · W&H Dentalwerk Buermoos GmbH · Dental
Jan 2010
Decision
388d
Days
Class 2
Risk

About This 510(k) Submission

K083811 is an FDA 510(k) clearance for the W&H HANDPIECE ANESTO, MODEL: RA-5, a Injector, Jet, Mechanical-powered (Class II — Special Controls, product code EGM), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on January 14, 2010, 388 days after receiving the submission on December 22, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.4475.

Submission Details

510(k) Number K083811 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2008
Decision Date January 14, 2010
Days to Decision 388 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGM — Injector, Jet, Mechanical-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4475