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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K051872
Device Name MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
Applicant
Mk-Dent GmbH
Eisenhutweg 15
Kumhausen,  DE 84036
Applicant Contact MARTINA GUNDEROTH
Correspondent
Mk-Dent GmbH
Eisenhutweg 15
Kumhausen,  DE 84036
Correspondent Contact MARTINA GUNDEROTH
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/11/2005
Decision Date 10/03/2005
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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