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FDA 510(k) Application Details - K242740
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K242740
Device Name
Powder, Porcelain
Applicant
Liaoning Rachcera Material Technology Co.,Ltd.
NO.31-1-5, Chang Qingnan Street, Hunnan New District
Shenyang 110000 CN
Other 510(k) Applications for this Company
Contact
Liang Chen
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
09/11/2024
Decision Date
12/05/2024
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
FDA Source Information for K242740
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