FDA 510(k) Application Details - K150432

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K150432
Device Name	Crown And Bridge, Temporary, Resin
Applicant	UNION DENTAL S.A. PASEO DE LA ESTACION, 4. TIELMES 28550 ES Other 510(k) Applications for this Company
Contact	JOSE LUIS RODRIGUEZ BLANCO Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2015
Decision Date	08/14/2015
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