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FDA 510(k) Application Details - K212259
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K212259
Device Name
Powder, Porcelain
Applicant
Zirdent New Material Co., Ltd
No.101,3rd building of Hai Ping International Medical Device
Industrial Area, No.229, Guyuan Road, Hi-tech New District
Changsha 410205 CN
Other 510(k) Applications for this Company
Contact
Jia Li
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/20/2021
Decision Date
11/12/2021
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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