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FDA 510(k)

C-Line Orthodontic Ceramic Bracket

K-Number: K163467 · 2017-06-14

ApplicantBiocetec Co., Ltd.
Decision Date2017-06-14
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

C-Line Orthodontic Ceramic Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K163467. 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 C-Line Orthodontic Ceramic Bracket?

C-Line Orthodontic Ceramic Bracket is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is Biocetec Co., Ltd.. The 510(k) number is K163467.

When did C-Line Orthodontic Ceramic Bracket receive FDA 510(k) clearance?

C-Line Orthodontic Ceramic Bracket received FDA 510(k) clearance on 2017-06-14, under 510(k) number K163467.

Who is the listed applicant for C-Line Orthodontic Ceramic Bracket?

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

What is the FDA product code for C-Line Orthodontic Ceramic Bracket?

The FDA product code for C-Line Orthodontic Ceramic Bracket is NJM.

Related Clinical Trials

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NCT07517601Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical TrialACTIVE_NOT_RECRUITING

Other records listing Biocetec Co., Ltd. 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.

K231635A-Line AdvancedK190871Bio-TackS Orthodontic Mini ImplantK182193S-Line

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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