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FDA 510(k)

Signature Orthodontic System

K-Number: K181271 · 2018-06-13

ApplicantSignature Orthodontics
Decision Date2018-06-13
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Signature Orthodontic System is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthodontics. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K181271. 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 Signature Orthodontic System?

Signature Orthodontic System is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Signature Orthodontics. The 510(k) number is K181271.

When did Signature Orthodontic System receive FDA 510(k) clearance?

Signature Orthodontic System received FDA 510(k) clearance on 2018-06-13, under 510(k) number K181271.

Who is the listed applicant for Signature Orthodontic System?

The FDA 510(k) record lists Signature Orthodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signature Orthodontic System?

The FDA product code for Signature Orthodontic System is NJM.

Other records listing Signature Orthodontics 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.

K183542Signature Orthodontic System

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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