NOBEL ACTIVE 3.0

Implant, Endosseous, Root-form

The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobel Active 3.0.

Device ID	K102436
510k Number	K102436
Device Name:	NOBEL ACTIVE 3.0
Classification	Implant, Endosseous, Root-form
Applicant	NOBEL BIOCARE AB 15 BOHUSGATAN, P.O. BOX 5190 Goteborg, SE S-402 26
Contact	Herbert Crane
Correspondent	Herbert Crane NOBEL BIOCARE AB 15 BOHUSGATAN, P.O. BOX 5190 Goteborg, SE S-402 26
Product Code	DZE
CFR Regulation Number	872.3640 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2010-08-26
Decision Date	2010-12-09
Summary:	summary