Portux CAD/CAM Disc— 510(k) K192153

Substantially Equivalent

New Stetic, SA

FDA 510(k) clearance K192153 for Portux CAD/CAM Disc, Substantially Equivalent on 2019-11-07. Applicant: New Stetic, SA. Device class: 2.

Clearance details

Applicant: New Stetic, SA
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2019-08-09
Decision date: 2019-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guarne - Antioquia, CO

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.