Cleared Abbreviated

Telio CAD Abutment Solutions

K151564 · Ivoclar Vivadent, AG · Dental

Sep 2015

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K151564 is an FDA 510(k) clearance for the Telio CAD Abutment Solutions, 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 September 21, 2015, 103 days after receiving the submission on June 10, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K151564 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2015
Decision Date	September 21, 2015
Days to Decision	103 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.