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)

DIO PROTEM IMPLANT SYSTEM

K-Number: K080126 · 2008-04-11

ApplicantDio Department Dsi, Inc.
Decision Date2008-04-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIO PROTEM IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dio Department Dsi, Inc.. It received FDA 510(k) clearance on 2008-04-11 under 510(k) number K080126. 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 DIO PROTEM IMPLANT SYSTEM?

DIO PROTEM IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-11. The listed applicant is Dio Department Dsi, Inc.. The 510(k) number is K080126.

When did DIO PROTEM IMPLANT SYSTEM receive FDA 510(k) clearance?

DIO PROTEM IMPLANT SYSTEM received FDA 510(k) clearance on 2008-04-11, under 510(k) number K080126.

Who is the listed applicant for DIO PROTEM IMPLANT SYSTEM?

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

What is the FDA product code for DIO PROTEM IMPLANT SYSTEM?

The FDA product code for DIO PROTEM 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 Dio Department Dsi, 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.

K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)K073070DIO BIOTITE-H IMPLANT SYSTEMK080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEMK070570DIO IMPLANT SYSTEMK070569SM INTERNAL./EXTERNAL IMPLANT SYSTEMK070568DIO PROTEM IMPLANT SYSTEM

View all 8 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.

↑