FX65

GUDID 04560264578517

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 04560264578517
• NIH Device Record Key: d51562a7-f43a-4c49-89d2-fd4655524f2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX65
• Version Model Number: FX65
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• 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	04560264578340 [Primary]
GS1	04560264578517 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230106

FDA Product Code

• EGS: Handpiece, contra- and right-angle attachment, dental

Sterilization

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

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

[04560264578517]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-16
• Device Publish Date: 2023-10-06

Devices Manufactured by NAKANISHI INC.

• 04560264575158 - Nozzle Holder: 2024-11-25
• 04560264575165 - Nozzle Holder: 2024-11-25
• 04560264575172 - Internal Spray Nozzle: 2024-11-25
• 04560264575189 - Cleaning Wire: 2024-11-25
• 04560264575271 - Tube Holder: 2024-11-25
• 04560264576506 - Protection Plug: 2024-11-25
• 04560264576513 - Coolant Solution Hanger Post: 2024-11-25
• 04589551392421 - Tube Holder: 2024-11-25