Cleared Abbreviated

IPS e.max CAD Abutment Solutions- extra systems

K191382 · Ivoclar Vivadent, AG · Dental

Aug 2019

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K191382 is an FDA 510(k) clearance for the IPS e.max 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 August 26, 2019, 95 days after receiving the submission on May 23, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K191382 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2019
Decision Date	August 26, 2019
Days to Decision	95 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.