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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 K904450
Device Name BIOCERAM DENTAL IMPLANT, SERIES II
Applicant
Kyocera America, Inc.
8611 Balboa Ave.
San Diego,  CA  92123
Applicant Contact KAZ HAYASHI
Correspondent
Kyocera America, Inc.
8611 Balboa Ave.
San Diego,  CA  92123
Correspondent Contact KAZ HAYASHI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/28/1990
Decision Date 07/09/1991
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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