FX15

GUDID 04560264578470

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 04560264578470
• NIH Device Record Key: ea9bb3e9-6da2-443e-8dcf-c9a43b96c5f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX15
• Version Model Number: FX15
• 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	04560264578302 [Primary]
GS1	04560264578470 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222518

FDA Product Code

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

Sterilization

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

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

[04560264578470]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-20
• Device Publish Date: 2023-03-10

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
• 04589551389391 - Surgic Pro2 OPT: 2024-10-23