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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 K112099
Device Name CONTOUR HEALER
Original Applicant
CONTOUR HEALER, LLC
1117 ditchley road
virginia beach,  VA  23451
Original Contact allen hardin white
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/22/2011
Decision Date 02/03/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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