Cleared Traditional

Root ZX3

K213477 · J. Morita USA, Inc. · Dental
Aug 2022
Decision
278d
Days
Class 2
Risk

About This 510(k) Submission

K213477 is an FDA 510(k) clearance for the Root ZX3, a Unit, Electrosurgical, And Accessories, Dental (Class II — Special Controls, product code EKZ), submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on August 3, 2022, 278 days after receiving the submission on October 29, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number K213477 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2021
Decision Date August 03, 2022
Days to Decision 278 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKZ — Unit, Electrosurgical, And Accessories, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4920

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