Cleared Abbreviated

K160798 - IPS e.max? Press Abutment Solutions for Viteo Base Ti
(FDA 510(k) Clearance)

K160798 · Ivoclar Vivadent, AG · Dental

Dec 2016

Decision

267d

Days

Class 2

Risk

K160798 is an FDA 510(k) clearance for the IPS e.max? Press Abutment Solutions for Viteo Base Ti, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on December 15, 2016, 267 days after receiving the submission on March 23, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K160798 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2016
Decision Date	December 15, 2016
Days to Decision	267 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.