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)

ZEN CORDLESS PROPHY SYSTEM

K-Number: K101612 · 2010-06-30

ApplicantDiscus Dental, LLC
Decision Date2010-06-30
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZEN CORDLESS PROPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Discus Dental, LLC. It received FDA 510(k) clearance on 2010-06-30 under 510(k) number K101612. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEN CORDLESS PROPHY SYSTEM?

ZEN CORDLESS PROPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-06-30. The listed applicant is Discus Dental, LLC. The 510(k) number is K101612.

When did ZEN CORDLESS PROPHY SYSTEM receive FDA 510(k) clearance?

ZEN CORDLESS PROPHY SYSTEM received FDA 510(k) clearance on 2010-06-30, under 510(k) number K101612.

Who is the listed applicant for ZEN CORDLESS PROPHY SYSTEM?

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

What is the FDA product code for ZEN CORDLESS PROPHY SYSTEM?

The FDA product code for ZEN CORDLESS PROPHY SYSTEM is EKX.

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 Discus Dental, LLC 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.

K102639SL3K101215NUANCEK093208SIMPLISEALK092417INSIGHT ULTRASONIC INSERTS

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., Ltd.

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.

↑