FDA 510(k) Application Details - K143758

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K143758
Device Name Implant, Endosseous, Root-Form
Applicant CLINICAL HOUSE EUROPE GMBH
OPFIKONERSTRASSE 10
BASSERSDORF 8303 CH
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Contact Judi Weissinger
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 12/31/2014
Decision Date 08/07/2015
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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