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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
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