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FDA 510(k) Application Details - K203824
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K203824
Device Name
Material, Impression
Applicant
Hygedent INC.
Room 210C, Building 4, No 5 Chaoqian Road
Beijing 102299 CN
Other 510(k) Applications for this Company
Contact
Peng Wang
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/29/2020
Decision Date
04/19/2021
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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