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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact