FDA 510(k) Application Details - K180899

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K180899
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 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	872.3630   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	04/06/2018
Decision Date	10/31/2018
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