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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K052741
Device Name IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES
Applicant
W&H Dentalwerk Buermoos GmbH
Ignaz Glaser St. 53
Buermoos,  AT A-5111
Applicant Contact GABRIELE WIENBECK
Correspondent
W&H Dentalwerk Buermoos GmbH
Ignaz Glaser St. 53
Buermoos,  AT A-5111
Correspondent Contact GABRIELE WIENBECK
Regulation Number872.4200
Classification Product Code
EBW  
Date Received09/30/2005
Decision Date 01/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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