FDA 510(k) Application Details - K980083

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K980083
Device Name Implant, Endosseous, Root-Form
Applicant IMPLANT INNOVATIONS, INC.
4555 RIVERSIDE DR.
PALM BEACH GARDENS, FL 33410 US
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Contact WILLIAM G CONETY
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 01/09/1998
Decision Date 08/17/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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