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FDA 510(k)

SAPPHIRE CERAMIC BRACKET

K-Number: K073045 · 2007-12-18

ApplicantOrtho Technology, Inc.
Decision Date2007-12-18
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE CERAMIC BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Technology, Inc.. It received FDA 510(k) clearance on 2007-12-18 under 510(k) number K073045. 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 SAPPHIRE CERAMIC BRACKET?

SAPPHIRE CERAMIC BRACKET is a medical device that received FDA 510(k) clearance on 2007-12-18. The listed applicant is Ortho Technology, Inc.. The 510(k) number is K073045.

When did SAPPHIRE CERAMIC BRACKET receive FDA 510(k) clearance?

SAPPHIRE CERAMIC BRACKET received FDA 510(k) clearance on 2007-12-18, under 510(k) number K073045.

Who is the listed applicant for SAPPHIRE CERAMIC BRACKET?

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

What is the FDA product code for SAPPHIRE CERAMIC BRACKET?

The FDA product code for SAPPHIRE CERAMIC BRACKET is NJM.

Related Clinical Trials

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.

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Other records listing Ortho Technology, 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.

K112707GENERATION C AESTHETIC SELF-LIGATING BRACKET 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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