Cleared Abbreviated

IPS E.MAX CAD ABUTMENT SOLUTIONS

K132209 · Ivoclar Vivadent, AG · Dental

Oct 2013

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K132209 is an FDA 510(k) clearance for the IPS E.MAX CAD ABUTMENT SOLUTIONS, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on October 31, 2013, 107 days after receiving the submission on July 16, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K132209 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2013
Decision Date	October 31, 2013
Days to Decision	107 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.