FDA 510(k) Application Details - K091390

Device Classification Name Implant, Endosseous, Orthodontic

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510(K) Number K091390
Device Name Implant, Endosseous, Orthodontic
Applicant HDC S.R.L.
VIA BORGO SANTA CRISTINA,12
IMOLA, BOLOGNA 4026 IT
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Contact GUIDO BONAPACE
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Regulation Number 872.3640

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Classification Product Code OAT
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Date Received 05/11/2009
Decision Date 07/30/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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