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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 K113301
Device Name CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
Applicant
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact JIM WATKINS
Correspondent
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact JIM WATKINS
Regulation Number872.4200
Classification Product Code
EFB  
Date Received11/08/2011
Decision Date 01/23/2012
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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