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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K103280
Device Name BHDENTAL IMPLANT SYSTEM
Applicant
BHDENTAL LTD
21 HANAFA STREET
ZUR-MOSHE,  IL 42810
Applicant Contact EILAT EZRA
Correspondent
BHDENTAL LTD
21 HANAFA STREET
ZUR-MOSHE,  IL 42810
Correspondent Contact EILAT EZRA
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received11/05/2010
Decision Date 02/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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