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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 K083192
Device Name INCLUSIVE TITANIUM ABUTMENT BLANKS
Applicant
Inclusive Dental Solutions
4141 Macarthur Blvd.
Newport Beach,  CA  92660
Applicant Contact KEITH D ALLRED
Correspondent
Inclusive Dental Solutions
4141 Macarthur Blvd.
Newport Beach,  CA  92660
Correspondent Contact KEITH D ALLRED
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/29/2008
Decision Date 03/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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