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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 K081806
Device Name IDI IMPLANT SYSTEM
Applicant
Idi Biomedical, LLC
104 2nd St. SE
Catawba,  NC  28609
Applicant Contact ANGELA BLACKWELL
Correspondent
Idi Biomedical, LLC
104 2nd St. SE
Catawba,  NC  28609
Correspondent Contact ANGELA BLACKWELL
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/26/2008
Decision Date 11/07/2008
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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