Cleared Traditional

IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES

K052741 · W&H Dentalwerk Buermoos GmbH · Dental
Jan 2006
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K052741 is an FDA 510(k) clearance for the IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES, 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 January 13, 2006, 105 days after receiving the submission on September 30, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K052741 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2005
Decision Date January 13, 2006
Days to Decision 105 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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