FX20K

GUDID 04589551390847

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 04589551390847
• NIH Device Record Key: 311779ab-3bfe-49c6-89aa-0d40e1c2ed10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FX20K
• Version Model Number: FX20K
• 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	04589551390557 [Primary]
GS1	04589551390847 [Direct Marking]

FDA Product Code

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

Sterilization

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

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

[04589551390847]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-04
• Device Publish Date: 2025-02-24

Devices Manufactured by NAKANISHI INC.

• 04589551390816 - FX20m: 2025-03-04
• 04589551390847 - FX20K: 2025-03-04
• 04589551390847 - FX20K: 2025-03-04
• 04589551390861 - FX57K: 2025-03-04
• 04589551390830 - FX58m: 2025-03-04
• 04589551390885 - FX50m: 2025-03-04
• 04589551390892 - FX50K: 2025-03-04
• 04589551390823 - FX55m: 2025-03-04
• 04560264572317 - H311L: 2025-03-04