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FDA 510(k)

Carriere SLX 3D Clear

K-Number: K173440 · 2018-03-08

ApplicantOrtho Organizers, Inc.
Decision Date2018-03-08
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Carriere SLX 3D Clear is a medical device manufactured by Ortho Organizers, Inc.. It received FDA 510(k) clearance on 2018-03-08 under approval number K173440. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carriere SLX 3D Clear?

Carriere SLX 3D Clear is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Ortho Organizers, Inc.. The 510(k) number is K173440.

When was Carriere SLX 3D Clear approved by the FDA?

Carriere SLX 3D Clear received FDA 510(k) clearance on 2018-03-08, under approval number K173440.

What company makes Carriere SLX 3D Clear?

Carriere SLX 3D Clear is manufactured by Ortho Organizers, Inc..

What is the FDA product code for Carriere SLX 3D Clear?

The FDA product code for Carriere SLX 3D Clear is NJM.

Other Devices by Ortho Organizers, Inc.

K160720Carriere Motion Clear Class II K252760Carriere® Motion Pro® Clear Bite Corrector

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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.

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