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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
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