FDA 510(k) Application Details - K153534

Device Classification Name	Teeth, Porcelain   More FDA Info for this Device
510(K) Number	K153534
Device Name	Teeth, Porcelain
Applicant	NOBEL BIOCARE AB BOX 5190, SE-402 26, VASTRA HAMNAGATAN 1 GOTEBORG SE-411 17 SE Other 510(k) Applications for this Company
Contact	Charlemagne Chua Other 510(k) Applications for this Contact
Regulation Number	872.3920   More FDA Info for this Regulation Number
Classification Product Code	ELL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2015
Decision Date	06/06/2016
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