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FDA 510(k) Application Details - K223194
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K223194
Device Name
Powder, Porcelain
Applicant
Shenzhen Xiangtong Co.,Ltd.
2nd F., 1st Bldg., West Area, Honghualing Industrial
Park, No.88, North Zhuguang Rd, Nanshan Dist.
Shenzhen 518055 CN
Other 510(k) Applications for this Company
Contact
Xue Gong
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
10/13/2022
Decision Date
02/10/2023
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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