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FDA 510(k) Application Details - K241924
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K241924
Device Name
Material, Impression
Applicant
Beijing OKVD Biological Technology Ltd.
101, 1st to 3rd Floors, Building 1, Yard 5, Dasheng Road
Shunyi District, Beijing (North Side of 1st Floor)
Beijing 101399 CN
Other 510(k) Applications for this Company
Contact
Zhang Xianghao
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
07/01/2024
Decision Date
12/27/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241924
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