Cleared Traditional

ELECTROTORQUE TLC

K103027 · Kaltenbach & Voigt GmbH · Dental
Aug 2011
Decision
310d
Days
Class 1
Risk

About This 510(k) Submission

K103027 is an FDA 510(k) clearance for the ELECTROTORQUE TLC, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Kaltenbach & Voigt GmbH (Orange, US). The FDA issued a Cleared decision on August 19, 2011, 310 days after receiving the submission on October 13, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K103027 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2010
Decision Date August 19, 2011
Days to Decision 310 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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