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)

BIOMERS TRANSLUCENT ORTHODONTIC BRACKET

K-Number: K101481 · 2010-06-23

ApplicantBiomers Products, LLC
Decision Date2010-06-23
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOMERS TRANSLUCENT ORTHODONTIC BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Biomers Products, LLC. It received FDA 510(k) clearance on 2010-06-23 under 510(k) number K101481. 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 BIOMERS TRANSLUCENT ORTHODONTIC BRACKET?

BIOMERS TRANSLUCENT ORTHODONTIC BRACKET is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Biomers Products, LLC. The 510(k) number is K101481.

When did BIOMERS TRANSLUCENT ORTHODONTIC BRACKET receive FDA 510(k) clearance?

BIOMERS TRANSLUCENT ORTHODONTIC BRACKET received FDA 510(k) clearance on 2010-06-23, under 510(k) number K101481.

Who is the listed applicant for BIOMERS TRANSLUCENT ORTHODONTIC BRACKET?

The FDA 510(k) record lists Biomers Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMERS TRANSLUCENT ORTHODONTIC BRACKET?

The FDA product code for BIOMERS TRANSLUCENT ORTHODONTIC 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.

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 Biomers Products, LLC 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.

K110796SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE

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.

↑