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FDA 510(k)

ORTHODONTIC CERAMIC BRACKETS 1.1

K-Number: K160615 · 2016-08-26

ApplicantTomy, Inc.
Decision Date2016-08-26
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC CERAMIC BRACKETS 1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Tomy, Inc.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K160615. 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 ORTHODONTIC CERAMIC BRACKETS 1.1?

ORTHODONTIC CERAMIC BRACKETS 1.1 is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Tomy, Inc.. The 510(k) number is K160615.

When did ORTHODONTIC CERAMIC BRACKETS 1.1 receive FDA 510(k) clearance?

ORTHODONTIC CERAMIC BRACKETS 1.1 received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160615.

Who is the listed applicant for ORTHODONTIC CERAMIC BRACKETS 1.1?

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

What is the FDA product code for ORTHODONTIC CERAMIC BRACKETS 1.1?

The FDA product code for ORTHODONTIC CERAMIC BRACKETS 1.1 is NJM.

Other records listing Tomy, 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.

K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

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

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

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