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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 the device name listed in this FDA 510(k) record. The listed applicant is Ortho Organizers, Inc.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) 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. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K173440.

When did Carriere SLX 3D Clear receive FDA 510(k) clearance?

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

Who is the listed applicant for Carriere SLX 3D Clear?

The FDA 510(k) record lists Ortho Organizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ortho Organizers, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252760Carriere® Motion Pro® Clear Bite CorrectorK160720Carriere Motion Clear Class II

Related Devices (Code: NJM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232827LightForce Orthodontic SystemLightforce OrthodonticsK232011CleoAmerican OrthodonticsK231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna FlexK222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce Orthodontics

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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