FDA 510(k) Application Details - K904450

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K904450
Device Name Implant, Endosseous, Root-Form
Applicant KYOCERA AMERICA, INC.
8611 BALBOA AVE.
SAN DIEGO, CA US
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Contact KAZ HAYASHI
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 09/28/1990
Decision Date 07/09/1991
Decision SE - Substantially Equivalent
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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