Cleared Abbreviated

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR

K090931 · W&H Dentalwerk Buermoos GmbH · Dental
Dec 2009
Decision
257d
Days
Class 1
Risk

About This 510(k) Submission

K090931 is an FDA 510(k) clearance for the CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, Salzburg, AT). The FDA issued a Cleared decision on December 15, 2009, 257 days after receiving the submission on April 2, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K090931 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2009
Decision Date December 15, 2009
Days to Decision 257 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKX — Handpiece, Direct Drive, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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