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FDA 510(k) Application Details - K152385
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K152385
Device Name
Implant, Endosseous, Root-Form
Applicant
DENTALPOINT AG
Hohlstrasse 614
Zurich 8048 CH
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Contact
Viktor Lienhard
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Regulation Number
872.3640
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Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
08/24/2015
Decision Date
07/27/2016
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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