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FDA 510(k) Application Details - K201915
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K201915
Device Name
Powder, Porcelain
Applicant
United Dental Resources Corporation
70 Towncenter Drive
University Park, IL 60484 US
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Contact
John Von Thaden
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
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More FDA Info for this Product Code
Date Received
07/10/2020
Decision Date
02/23/2021
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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