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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 K112623
Device Name AIRLIGHT DENTAL HANDPIECE
Applicant
BEYES DENTAL CANADA INC
3500 SOUTH DUPONT HIGHWAY
DOVER,  DE  19901
Applicant Contact ANTHONY HOPKINS
Correspondent
BEYES DENTAL CANADA INC
3500 SOUTH DUPONT HIGHWAY
DOVER,  DE  19901
Correspondent Contact ANTHONY HOPKINS
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/08/2011
Decision Date 12/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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