FDA 510(k) Application Details - K181331

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K181331
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Juvora, Ltd. Technology Centre, Hillhouse International Thornton-Clevelys FY5 4QD GB Other 510(k) Applications for this Company
Contact	Tim Leyva Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2018
Decision Date	12/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review