FDA 510(k) Application Details - K201241

Device Classification Name	Barrier, Animal Source, Intraoral   More FDA Info for this Device
510(K) Number	K201241
Device Name	Barrier, Animal Source, Intraoral
Applicant	Orthocell Ltd Building 191 Murdoch University, South St, MURDOCH Perth 6150 AU Other 510(k) Applications for this Company
Contact	Alison Carleton Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2020
Decision Date	01/11/2021
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