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)

GEM ORTHODONTIC BRACKET

K-Number: K870536 · 1987-02-19

ApplicantOrmco Corp.
Decision Date1987-02-19
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GEM ORTHODONTIC BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1987-02-19 under 510(k) number K870536. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEM ORTHODONTIC BRACKET?

GEM ORTHODONTIC BRACKET is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Ormco Corp.. The 510(k) number is K870536.

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

GEM ORTHODONTIC BRACKET received FDA 510(k) clearance on 1987-02-19, under 510(k) number K870536.

Who is the listed applicant for GEM ORTHODONTIC BRACKET?

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

What is the FDA product code for GEM ORTHODONTIC BRACKET?

The FDA product code for GEM ORTHODONTIC BRACKET is EJF.

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 Ormco Corp. 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.

K123118INSIGNIA DIGICASTK123416INSIGNIA WITH ITEROK122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEK121524INSIGNIAK112640HYPERELASTIC WIREK101676CLEARARCH

View all 39 devices →

Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, Inc.

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.

↑