FDA 510(k) Application Details - K982925

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K982925
Device Name Implant, Endosseous, Root-Form
Applicant IMPLADENT, LTD.
198-45 FOOTHILL AVE.
HOLLISWOOD, NY 11423 US
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Contact MAURICE VALEN
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 08/20/1998
Decision Date 05/18/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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