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)

HG III FIXTURE SYSTEM

K-Number: K093352 · 2009-11-24

ApplicantHiossen, Inc.
Decision Date2009-11-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HG III FIXTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hiossen, Inc.. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K093352. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HG III FIXTURE SYSTEM?

HG III FIXTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Hiossen, Inc.. The 510(k) number is K093352.

When did HG III FIXTURE SYSTEM receive FDA 510(k) clearance?

HG III FIXTURE SYSTEM received FDA 510(k) clearance on 2009-11-24, under 510(k) number K093352.

Who is the listed applicant for HG III FIXTURE SYSTEM?

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

What is the FDA product code for HG III FIXTURE SYSTEM?

The FDA product code for HG III FIXTURE SYSTEM is DZE.

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 Hiossen, 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.

K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsK251427EK MULTI ANGLED 30 ABUTMENTK241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)K240232EK D3.3 and Ultra Wide ImplantsK233389EK Digital AbutmentsK222636ET Abutment System

View all 25 devices →

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.

↑