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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 K002469
Device Name IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
Applicant
W&H Dentalwerk Buermoos GmbH
Ignaz Glaser St. 53
Buermoos,  AT A-5111
Applicant Contact HERBERT TRASCHWANDTNER
Correspondent
W&H Dentalwerk Buermoos GmbH
Ignaz Glaser St. 53
Buermoos,  AT A-5111
Correspondent Contact HERBERT TRASCHWANDTNER
Regulation Number872.4200
Classification Product Code
EBW  
Date Received08/11/2000
Decision Date 02/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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