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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 a medical device manufactured by Signature Orthodontics. It received FDA 510(k) clearance on 2018-06-13 under approval 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. It is manufactured by Signature Orthodontics. The 510(k) number is K181271.

When was Signature Orthodontic System approved by the FDA?

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

What company makes Signature Orthodontic System?

Signature Orthodontic System is manufactured by Signature Orthodontics.

What is the FDA product code for Signature Orthodontic System?

The FDA product code for Signature Orthodontic System is NJM.

Related Clinical Trials

NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05006339 The Use of Remote Monitoring for Orthodontic Retention Review ACTIVE_NOT_RECRUITING NCT05905224 Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol COMPLETED NCT07318623 Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems NOT_YET_RECRUITING NCT07264127 Clinical Performance of the I-arch System During the Initial Stage of Orthodontic Treatment RECRUITING

Other Devices by Signature Orthodontics

K183542Signature Orthodontic System

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K160615ORTHODONTIC CERAMIC BRACKETS 1.1Tomy, Inc. K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd. K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. K163117Alpha PureKoroad America

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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