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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 K082299
Device Name VERICORE IMPLANT ABUTMENTS
Applicant
Whip-Mix Corp.
361 Farmington Ave.
Louisville,  KY  40217
Applicant Contact DAVID J STEINBOCK
Correspondent
Whip-Mix Corp.
361 Farmington Ave.
Louisville,  KY  40217
Correspondent Contact DAVID J STEINBOCK
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/12/2008
Decision Date 11/20/2008
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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