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)

MIS DENTAL IMPLANT SYSTEM

K-Number: K040807 · 2004-06-09

ApplicantMis - Implant Technologies , Ltd.
Decision Date2004-06-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mis - Implant Technologies , Ltd.. It received FDA 510(k) clearance on 2004-06-09 under 510(k) number K040807. 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 MIS DENTAL IMPLANT SYSTEM?

MIS DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-09. The listed applicant is Mis - Implant Technologies , Ltd.. The 510(k) number is K040807.

When did MIS DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

MIS DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2004-06-09, under 510(k) number K040807.

Who is the listed applicant for MIS DENTAL IMPLANT SYSTEM?

The FDA 510(k) record lists Mis - Implant Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS DENTAL IMPLANT SYSTEM?

The FDA product code for MIS DENTAL IMPLANT 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 Mis - Implant Technologies , 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.

K103089SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTSK080458MIS CREST WIDENER

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.

↑