FDA 510(k) Application Details - K170849

Device Classification Name Accessories, Implant, Dental, Endosseous

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510(K) Number K170849
Device Name Accessories, Implant, Dental, Endosseous
Applicant Dentsply Sirona
221 West Philadelphia Street
Suite 60W
York, PA 17401 US
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Contact Helen Lewis
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Regulation Number 872.3980

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Classification Product Code NDP
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Date Received 03/22/2017
Decision Date 06/15/2017
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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