FDA 510(k) Application Details - K073622

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K073622
Device Name Implant, Endosseous, Root-Form
Applicant T.F.I. SYSTEM S.R.L
VIA ALESSANDRO D'ANCONA 23
ROMA (RM) 00137 IT
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Contact DOTT. CLAUDIO MECHELLI
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 12/26/2007
Decision Date 05/14/2008
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

FDA Source Information for K073622


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