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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 K902402
Device Name HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE
Applicant
Dentalez Group
1818 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact GARY FOSS
Correspondent
Dentalez Group
1818 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact GARY FOSS
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/31/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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