J. MORITA MFG. CORP.

GUDID 04548213055999

Revised version of TR-ZX2 from 2023.

J.MORITA MFG.CORP.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 04548213055999
• NIH Device Record Key: 7173d21b-def3-4748-91bf-1ee2a677d2ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: J. MORITA MFG. CORP.
• Version Model Number: TR-ZX2 Type PLUS
• Company DUNS: 693811465
• Company Name: J.MORITA MFG.CORP.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548213055999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170275

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

[04548213055999]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-14
• Device Publish Date: 2023-03-06

On-Brand Devices [J. MORITA MFG. CORP.]

• 04548213027408: Attachments for Air and Electric Motors
• 04548213055999: Revised version of TR-ZX2 from 2023.