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)

STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET

K-Number: K874226 · 1987-12-29

ApplicantAdvanced Orthodontics Systems, Inc.
Decision Date1987-12-29
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthodontics Systems, Inc.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K874226. 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 STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET?

STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Advanced Orthodontics Systems, Inc.. The 510(k) number is K874226.

When did STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET receive FDA 510(k) clearance?

STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET received FDA 510(k) clearance on 1987-12-29, under 510(k) number K874226.

Who is the listed applicant for STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET?

The FDA 510(k) record lists Advanced Orthodontics Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET?

The FDA product code for STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW 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 Advanced Orthodontics Systems, Inc. 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.

K920781FLASH BONDK874228BOND FAST NO MIX ADHESIVEK874227PLASTIC BRACKETS

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.

↑