FDA 510(k) Application Details - K130198

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K130198
Device Name	Powder, Porcelain
Applicant	NEO GROUP LIMITED ROOM Q1D G/F, KAISER EST 3RD PHASE, 18 MAN LOK ST HUNG HOM, KOWLOON HK 852 HK Other 510(k) Applications for this Company
Contact	MIKE ADAMS Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/28/2013
Decision Date	10/21/2013
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