Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Portux CAD/CAM Disc

K-Number: K192153 · 2019-11-07

ApplicantNew Stetic, SA
Decision Date2019-11-07
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Portux CAD/CAM Disc is a medical device manufactured by New Stetic, SA. It received FDA 510(k) clearance on 2019-11-07 under approval number K192153. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portux CAD/CAM Disc?

Portux CAD/CAM Disc is a medical device that received FDA 510(k) clearance on 2019-11-07. It is manufactured by New Stetic, SA. The 510(k) number is K192153.

When was Portux CAD/CAM Disc approved by the FDA?

Portux CAD/CAM Disc received FDA 510(k) clearance on 2019-11-07, under approval number K192153.

What company makes Portux CAD/CAM Disc?

Portux CAD/CAM Disc is manufactured by New Stetic, SA.

What is the FDA product code for Portux CAD/CAM Disc?

The FDA product code for Portux CAD/CAM Disc is EBG.

Other Devices by New Stetic, SA

K254245ZAFIRA®

Related Devices (Code: EBG)

K153490DD medical polymersDental Direkt GmbH K152443Vericore Gradient Temporary DiscWhip Mix Corporation K153753TelioCAD MultiIvoclar Vivadent, Inc. K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLORDentalplus GmbH K171729Fixtemp C&BDreve Dentamid GmbH K172281PuRE PMMA DiscQuest Dental USA Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑