Cleared Traditional

K120053 - IPS E.MAX PRESS - ABUTMENT SOLUTIONS
(FDA 510(k) Clearance)

K120053 · Ivoclar Vivadent, AG · Dental

Oct 2012

Decision

286d

Days

Class 2

Risk

K120053 is an FDA 510(k) clearance for the IPS E.MAX PRESS - 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 18, 2012, 286 days after receiving the submission on January 6, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K120053 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2012
Decision Date	October 18, 2012
Days to Decision	286 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

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.