Root ZX3— 510(k) K213477

Substantially Equivalent

J. Morita USA, Inc.

FDA 510(k) clearance K213477 for Root ZX3, Substantially Equivalent on 2022-08-03. Applicant: J. Morita USA, Inc.. Device class: 2.

Clearance details

Applicant: J. Morita USA, Inc.
Product code: Code EKZ
Device class: Class 2
Regulation: 21 CFR 872.4920
Advisory panel: Dental
Date received: 2021-10-29
Decision date: 2022-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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