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FDA 510(k)

FASTBRACES CERAMIC BRACKETS

K-Number: K130446 · 2013-06-07

ApplicantOrthodontic Design and Production, Inc.
Decision Date2013-06-07
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FASTBRACES CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is Orthodontic Design and Production, Inc.. It received FDA 510(k) clearance on 2013-06-07 under 510(k) number K130446. 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 FASTBRACES CERAMIC BRACKETS?

FASTBRACES CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2013-06-07. The listed applicant is Orthodontic Design and Production, Inc.. The 510(k) number is K130446.

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

FASTBRACES CERAMIC BRACKETS received FDA 510(k) clearance on 2013-06-07, under 510(k) number K130446.

Who is the listed applicant for FASTBRACES CERAMIC BRACKETS?

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

What is the FDA product code for FASTBRACES CERAMIC BRACKETS?

The FDA product code for FASTBRACES CERAMIC BRACKETS is NJM.

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Other records listing Orthodontic Design and Production, 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.

K132368VAPOR CERAMIC BRACKET

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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