FDA 510(k) Application Details - K151432

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K151432
Device Name Abutment, Implant, Dental, Endosseous
Applicant OT MEDICAL GMBH
KONSUL-SMIDT-STR. 8B
BREMEN D-28217 DE
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Contact MARTINA BEHLAU
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 05/28/2015
Decision Date 11/05/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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