Cleared Traditional

Portux CAD/CAM Disc

K192153 · New Stetic, SA · Dental

Nov 2019

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K192153 is an FDA 510(k) clearance for the Portux CAD/CAM Disc, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by New Stetic, SA (Guarne - Antioquia, CO). The FDA issued a Cleared decision on November 7, 2019, 90 days after receiving the submission on August 9, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K192153 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2019
Decision Date	November 07, 2019
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF