FDA 510(k) Application Details - K202413

Device Classification Name	Liner, Cavity, Calcium Hydroxide   More FDA Info for this Device
510(K) Number	K202413
Device Name	Liner, Cavity, Calcium Hydroxide
Applicant	S&C Polymer Silicon- und Composite Spezialitaten GmbH Robert-Bosch-Str. 2 Elmshorn 25335 DE Other 510(k) Applications for this Company
Contact	Christian Bottcher Other 510(k) Applications for this Contact
Regulation Number	872.3250   More FDA Info for this Regulation Number
Classification Product Code	EJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2020
Decision Date	11/20/2020
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