Cleared Traditional

K213477 - Root ZX3

K213477 is an FDA 510(k) clearance for Root ZX3, manufactured by J. Morita USA, Inc.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K213477 · J. Morita USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
278d
Days
Class 2
Risk

K213477 is an FDA 510(k) clearance for the Root ZX3. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on August 3, 2022 after a review of 278 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K213477

510(k) Number K213477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 128d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EKZ Device Classification - Class 2, Special Controls

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Fish & Richardson, P.C.
Keith A. Barritt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EKZ Unit, Electrosurgical, And Accessories, Dental

All 18
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K213477.
PERFECT TISSUE CONTOURING SYSTEM II
K071632 · Coltene/Whaledent, Inc. · Oct 2007
THE FUGO BLADE FOR DENTISTRY
K063468 · Medisurg , Ltd. · Apr 2007
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
K052622 · Macan Engineering Co. · Dec 2005
MC6A
K050735 · Macan Engineering Co. · May 2005
X O ODONTOSURGE 4
K023672 · Xo Care A/S · Apr 2003
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · Diagnostic Data, Inc. · Feb 2002
K213477 · Root ZX3
Download PDF FDA Summary J. Morita USA, Inc.