Cleared Abbreviated

Telio CAD Abutment Solutions- extra systems

K193193 · Ivoclar Vivadent, AG · Dental

Nov 2020

Decision

363d

Days

Class 2

Risk

About This 510(k) Submission

K193193 is an FDA 510(k) clearance for the Telio CAD Abutment Solutions- extra systems, 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 November 16, 2020, 363 days after receiving the submission on November 19, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K193193 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2019
Decision Date	November 16, 2020
Days to Decision	363 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.