Tri Auto ZX2

Basic Information

• Brand Name: Tri Auto ZX2
• Primary DI: 04548213027064
• Version / Model: TR-ZX2
• Company Name: J.MORITA MFG.CORP.
• Labeler DUNS: 693811465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: c8306924-d0df-481f-93c3-265f8ce96fa3

Device Description

Cordless Endo Motor with Apex Locator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1
LQY	Locator, Root Apex	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
66245	Dental surgical power tool motorized handpiece/set, electric	An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.	No	Active
16355	Endodontic apex locator	A dental instrument, using electricity, designed to locate the top of the root canal during endodontic procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04548213027064	GS1

Premarket Submissions

Submission Number	Supplement Number
K170275	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 80 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius