FDA 510(k) Application Details - K140440

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K140440
Device Name Implant, Endosseous, Root-Form
Applicant NORIS MEDICAL LTD.
8 HATAASIA
NESHER 3688808 IL
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Contact RAANAN ALONI
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 02/21/2014
Decision Date 12/19/2014
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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