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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K854763
Device Name CERAPEARL
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 Number872.6660
Classification Product Code
EIH  
Date Received11/27/1985
Decision Date 02/21/1986
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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