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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 K860360
Device Name KYOCERA BIOCERAM POROUS DENTAL IMPLANT
Applicant
Kyocera International, Inc.
8611 Balboa Ave.
San Diego,  CA  92123
Applicant Contact BARRY CALVARESE
Correspondent
Kyocera International, Inc.
8611 Balboa Ave.
San Diego,  CA  92123
Correspondent Contact BARRY CALVARESE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/30/1986
Decision Date 04/04/1986
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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