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)

INTERMEZZO IMPLANT SYSTEMS

K-Number: K051018 · 2005-09-02

ApplicantMegagen Co., Ltd.
Decision Date2005-09-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTERMEZZO IMPLANT SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Co., Ltd.. It received FDA 510(k) clearance on 2005-09-02 under 510(k) number K051018. 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 INTERMEZZO IMPLANT SYSTEMS?

INTERMEZZO IMPLANT SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-09-02. The listed applicant is Megagen Co., Ltd.. The 510(k) number is K051018.

When did INTERMEZZO IMPLANT SYSTEMS receive FDA 510(k) clearance?

INTERMEZZO IMPLANT SYSTEMS received FDA 510(k) clearance on 2005-09-02, under 510(k) number K051018.

Who is the listed applicant for INTERMEZZO IMPLANT SYSTEMS?

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

What is the FDA product code for INTERMEZZO IMPLANT SYSTEMS?

The FDA product code for INTERMEZZO IMPLANT SYSTEMS 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 Megagen Co., Ltd. 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.

K110955ANYRIDGE INTERNAL IMPLANT SYSTEMK101890BALL ABUTMENT SYSTEMK073058RESCUE INTERNAL IMPLANT SYSTEMK070562EZ PLUS IMPLANT SYSTEMK063216RESCUE INTERNAL IMPLANT SYSTEMK053353RESCUE IMPLANT SYSTEM

View all 9 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.

↑