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FDA 510(k)

EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS

K-Number: K131197 · 2013-08-27

ApplicantDental Morelli
Decision Date2013-08-27
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is Dental Morelli. It received FDA 510(k) clearance on 2013-08-27 under 510(k) number K131197. 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 EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS?

EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2013-08-27. The listed applicant is Dental Morelli. The 510(k) number is K131197.

When did EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS receive FDA 510(k) clearance?

EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS received FDA 510(k) clearance on 2013-08-27, under 510(k) number K131197.

Who is the listed applicant for EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS?

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

What is the FDA product code for EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS?

The FDA product code for EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS is NJM.

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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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