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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 K061323
Device Name MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM
Applicant
Bioinfera, Inc.
23230 Chagrin Blvd.
Suite # 950
Beachwood,  OH  44122
Applicant Contact CHAN Q WANG
Correspondent
Bioinfera, Inc.
23230 Chagrin Blvd.
Suite # 950
Beachwood,  OH  44122
Correspondent Contact CHAN Q WANG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/11/2006
Decision Date 05/23/2007
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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