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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 K062876
Device Name PRIMACONNEX CERAMIC ABUTMENTS
Applicant
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Applicant Contact BRIAN SMEKAL
Correspondent
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Correspondent Contact BRIAN SMEKAL
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/26/2006
Decision Date 11/01/2006
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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