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FDA 510(k) Application Details - K162654
Device Classification Name
Resin, Denture, Relining, Repairing, Rebasing
More FDA Info for this Device
510(K) Number
K162654
Device Name
Resin, Denture, Relining, Repairing, Rebasing
Applicant
DETAX GmbH & Co.KG
Carl-Zeiss-Str. 4
Ettlingen 76275 DE
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Contact
Antje Reeps
Other 510(k) Applications for this Contact
Regulation Number
872.3760
More FDA Info for this Regulation Number
Classification Product Code
EBI
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More FDA Info for this Product Code
Date Received
09/23/2016
Decision Date
03/13/2017
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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