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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K030133
Device Name SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
Applicant
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact WILLIAM GUSCOTT
Correspondent
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact WILLIAM GUSCOTT
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/14/2003
Decision Date 04/29/2003
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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