FDA 510(k) Application Details - K071490

Device Classification Name Implant, Endosseous, Orthodontic

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510(K) Number K071490
Device Name Implant, Endosseous, Orthodontic
Applicant LEONE SPA
50, VIA P. A QUARACCHI
SESTO, FIORENTINO I-50019 IT
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Contact ELIA LADANI
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Regulation Number 872.3640

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Classification Product Code OAT
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Date Received 05/30/2007
Decision Date 02/22/2008
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



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