Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CLARITY ADVANCED CERAMIC BRACKETS

K-Number: K102803 · 2011-02-17

Applicant3M Unitek Corporation
Decision Date2011-02-17
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLARITY ADVANCED CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is 3M Unitek Corporation. It received FDA 510(k) clearance on 2011-02-17 under 510(k) number K102803. 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 CLARITY ADVANCED CERAMIC BRACKETS?

CLARITY ADVANCED CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2011-02-17. The listed applicant is 3M Unitek Corporation. The 510(k) number is K102803.

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

CLARITY ADVANCED CERAMIC BRACKETS received FDA 510(k) clearance on 2011-02-17, under 510(k) number K102803.

Who is the listed applicant for CLARITY ADVANCED CERAMIC BRACKETS?

The FDA 510(k) record lists 3M Unitek Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARITY ADVANCED CERAMIC BRACKETS?

The FDA product code for CLARITY ADVANCED CERAMIC BRACKETS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing 3M Unitek 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.

K1636893M Clear Tray AlignerK113197APC FLASH-FREE ADHESIVE

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.

↑