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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K960507
Device Name STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES
Applicant
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact JEFF PEINHARDT
Correspondent
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact JEFF PEINHARDT
Regulation Number872.4200
Classification Product Code
EFA  
Date Received02/05/1996
Decision Date 03/28/1996
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
Recalls CDRH Recalls
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