FX204 M4

GUDID 04560264578586

NAKANISHI INC.

Dental surgical power tool motor, pneumatic

• Primary Device ID: 04560264578586
• NIH Device Record Key: d12b3c00-7245-460d-9c3e-86cb0a9ee6da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX204 M4
• Version Model Number: FX204 M4
• 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	04560264578425 [Primary]
GS1	04560264578586 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233308

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

[04560264578586]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-24
• Device Publish Date: 2024-10-16

Devices Manufactured by NAKANISHI INC.

• 04589551383993 - Bur Stopper: 2024-11-21
• 04589551384006 - Bur Stopper Puller: 2024-11-21
• 04560264502963 - PTL Nozzle: 2024-11-11
• 04560264502970 - EZ-M4 Adaptor: 2024-11-11
• 04589551392063 - EZ SPRAY: 2024-11-11
• 04589551391950 - M205: 2024-10-24
• 04560264578586 - FX204 M4: 2024-10-24
• 04560264578586 - FX204 M4: 2024-10-24
• 04589551389391 - Surgic Pro2 OPT: 2024-10-23