FDA 510(k) Application Details - K221851

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K221851
Device Name	Barrier, Synthetic, Intraoral
Applicant	Criteria Industria e Comercio de Produtos Medicinais e Odontologicos LTDA Alameda Sinlioku Tanaka, 170, Galpao 44- Parque Technologico Sao Carlos 13.565-261 BR Other 510(k) Applications for this Company
Contact	Andre Hamar Braga Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2022
Decision Date	12/08/2023
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