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FDA 510(k) Application Details - K170050
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K170050
Device Name
Powder, Porcelain
Applicant
Metoxit AG
Emdwiesenstrasse 6
Thayngen CH-8240 CH
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Contact
Dipl.-Ing Stefan Leyen
Other 510(k) Applications for this Contact
Regulation Number
872.6660
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Classification Product Code
EIH
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More FDA Info for this Product Code
Date Received
01/05/2017
Decision Date
08/23/2018
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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