Cleared Traditional

DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM

K060287 · W&H Dentalwerk Buermoos GmbH · Dental
May 2006
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K060287 is an FDA 510(k) clearance for the DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on May 3, 2006, 86 days after receiving the submission on February 6, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K060287 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2006
Decision Date May 03, 2006
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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