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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K101755
Device Name AIDI DENTAL IMPLANT SYSTEM
Applicant
Aidi Biomedical, LLC
34859 Frederick St.
#105
Wildomar,  CA  92595
Applicant Contact WILLIAM Y.S. HUNG
Correspondent
Aidi Biomedical, LLC
34859 Frederick St.
#105
Wildomar,  CA  92595
Correspondent Contact WILLIAM Y.S. HUNG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/23/2010
Decision Date 11/22/2010
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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