FDA 510(k) Application Details - K141970

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K141970
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	DIGITEK DENTAL SOLUTIONS LIMITED 93 KINGLAM ST, CHEUNG SHA WAN UNITS B-C FLAT D, 6/F KOWLOON, HONG KONG 999077 CN Other 510(k) Applications for this Company
Contact	ALWIN NGAI Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2014
Decision Date	07/31/2015
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