FDA 510(k) Application Details - K203072

Device Classification Name	Teeth, Porcelain   More FDA Info for this Device
510(K) Number	K203072
Device Name	Teeth, Porcelain
Applicant	Franz Biotech Inc. 5F.-3, No. 56, Ln. 258, Ruiguang Rd., Neihu Dist. Taipei City 114 TW Other 510(k) Applications for this Company
Contact	Anita Chen Other 510(k) Applications for this Contact
Regulation Number	872.3920   More FDA Info for this Regulation Number
Classification Product Code	ELL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2020
Decision Date	01/19/2022
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