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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 K043428
Device Name RELIADENT DENTAL IMPLANT SYSTEM
Applicant
BIOINFERA, INC.
21205 HALWORTH ROAD
BEACHWOOD,  OH  44122
Applicant Contact CHAN Q WANG
Correspondent
BIOINFERA, INC.
21205 HALWORTH ROAD
BEACHWOOD,  OH  44122
Correspondent Contact CHAN Q WANG
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/13/2004
Decision Date 07/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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