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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 K032234
Device Name MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
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 Received07/21/2003
Decision Date 10/02/2003
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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