FDA 510(k) Application Details - K120793

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K120793
Device Name Implant, Endosseous, Root-Form
Applicant Z-Systems AG
11234 EL CAMINO REAL
STE: 200
SAN DIEGO, CA 92024 US
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Contact LINDA SCHULZ
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 03/15/2012
Decision Date 12/21/2012
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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