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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 K070869
Device Name PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422
Applicant
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact WILLIAM GUSCOTT
Correspondent
Dentalez, Inc.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact WILLIAM GUSCOTT
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/29/2007
Decision Date 06/15/2007
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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