FDA 510(k) Application Details - K211854

Device Classification Name	Coating, Filling Material, Resin   More FDA Info for this Device
510(K) Number	K211854
Device Name	Coating, Filling Material, Resin
Applicant	VITA Zahnfabrik GmbH H Rauter & Co Spitelgasse 3 Bad Sackingen D-79713 DE Other 510(k) Applications for this Company
Contact	Bernd Walker Other 510(k) Applications for this Contact
Regulation Number	872.3310   More FDA Info for this Regulation Number
Classification Product Code	EBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2021
Decision Date	11/22/2021
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