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FDA 510(k) Application Details - K150203
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K150203
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
MEDENTIKA GMBH
HAMMWEG 8-10
HUEGELSHEIM 76549 DE
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Contact
Dr. Gerhard Polzer
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Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
01/29/2015
Decision Date
10/23/2015
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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