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)

ROOT ZX II

K-Number: K071190 · 2007-08-17

ApplicantJ. Morita USA, Inc.
Decision Date2007-08-17
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT ZX II is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K071190. 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 ROOT ZX II?

ROOT ZX II is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K071190.

When did ROOT ZX II receive FDA 510(k) clearance?

ROOT ZX II received FDA 510(k) clearance on 2007-08-17, under 510(k) number K071190.

Who is the listed applicant for ROOT ZX II?

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

What is the FDA product code for ROOT ZX II?

The FDA product code for ROOT ZX II is EKX.

Other records listing J. Morita USA, 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.

K213477Root ZX3K2013783D Accuitomo 150NK190509Lubrina 2K173920LS OILK171012Veraview X800K170275Tri Auto ZX2

View all 52 devices →

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.

↑