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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K913255
Device Name CERAMIC(TM) ABUTMENT
Applicant
Ceramic Core Corp.
6120 Brandon Ave., Suite 312
Springfield,  VA  22150
Applicant Contact VINCENT PRESTIPINO
Correspondent
Ceramic Core Corp.
6120 Brandon Ave., Suite 312
Springfield,  VA  22150
Correspondent Contact VINCENT PRESTIPINO
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/08/1991
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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