Tri Auto ZX2

FDA UDI

Class I (US FDA UDI)

by J.morita Mfg.corp.

Identity

Trade Name: Tri Auto ZX2 FDA UDI
Generic Name: Dental surgical power tool motorized handpiece/set, electric FDA UDI
Device Name: Cordless Endo Motor with Apex Locator FDA UDI
Model / Reference: TR-ZX2 FDA UDI
Description: Cordless Endo Motor with Apex Locator FDA UDI

Identifiers

Primary DI / UDI-DI: 04548213027064 FDA UDI
510(k) Number: K170275 FDA UDI
FDA Product Code: EKX FDA UDI
LQY FDA UDI
GMDN Term: Dental surgical power tool motorized handpiece/set, electric FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental surgical power tool motorized handpiece/set, electric Endodontic apex locator

Tri Auto ZX2 by J.morita Mfg.corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endodontic apex locator.

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Medidenta — Guilin Woodpecker Medical Instrument Co., Ltd. · U
PATTERSON — PATTERSON DENTAL SUPPLY, INC. · U
DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · U
EndoPilot Komet — Schlumbohm GmbH & Co. KG · U
Henry Schein — HENRY SCHEIN, INC. · U
EndoPilot Cap for lip-contact — Schlumbohm GmbH & Co. KG · U

Cleared under the same submission

K170275 also covers:

J. MORITA MFG. CORP. — J.MORITA MFG.CORP.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: J.morita Mfg.corp.

Sources (1)

FDA UDI c8306924-d0df-481f-93c3-265f8ce96fa3 35 fields · synced Jun 8, 2026