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FDA 510(k)

CDB Self Ligating Bracket 8F

K-Number: K160957 · 2016-09-27

ApplicantCdb Corporation
Decision Date2016-09-27
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CDB Self Ligating Bracket 8F is the device name listed in this FDA 510(k) record. The listed applicant is Cdb Corporation. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K160957. 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 CDB Self Ligating Bracket 8F?

CDB Self Ligating Bracket 8F is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Cdb Corporation. The 510(k) number is K160957.

When did CDB Self Ligating Bracket 8F receive FDA 510(k) clearance?

CDB Self Ligating Bracket 8F received FDA 510(k) clearance on 2016-09-27, under 510(k) number K160957.

Who is the listed applicant for CDB Self Ligating Bracket 8F?

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

What is the FDA product code for CDB Self Ligating Bracket 8F?

The FDA product code for CDB Self Ligating Bracket 8F 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.

NCT07638397Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner SystemNOT_YET_RECRUITINGNCT07712055A Study to Evaluate the Relationship Between Two Bracket System and Their Contribution to Initial Alignment of Maxillary Anteriors - De Crowding, Smile Arc Protection.COMPLETED

Other records listing Cdb Corporation 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.

K212173HDH Treatment Planning SystemK210613HIT Clear AlignerK191823Clear-Aligners

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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