FDA 510(k) Application Details - K200040

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K200040
Device Name Abutment, Implant, Dental, Endosseous
Applicant Nobel Biocare AG
Balz Zimmermann-Strasse 7
Kloten Zurich 8302 CH
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Contact Bernice Jim
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 01/08/2020
Decision Date 03/30/2020
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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