FDA 510(k) Application Details - K033630

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K033630
Device Name Implant, Endosseous, Root-Form
Applicant RHEIN 83 SRL
132 MONROE ST.
HOBOKEN, NJ 07030 US
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Contact JOSEPH E GRASSO
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 11/17/2003
Decision Date 04/21/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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