FDA 510(k) Application Details - K160382

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K160382
Device Name Abutment, Implant, Dental, Endosseous
Applicant RHEIN'83 SRL
VIA E. ZAGO 10/ABC
BOLOGNA 40128 IT
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Contact CLAUDIA NARDI
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 02/10/2016
Decision Date 08/11/2016
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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