VA2-LUX-HP Ti

GUDID 04560264577763

NAKANISHI INC.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 04560264577763
• NIH Device Record Key: 5ac90065-2387-4f3b-a603-f2aac5dc514e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VA2-LUX-HP Ti
• Version Model Number: VA2-LUX-HP Ti
• 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	04560264577763 [Direct Marking]
GS1	04589551392919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251689

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

[04560264577763]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-23
• Device Publish Date: 2026-02-13

Devices Manufactured by NAKANISHI INC.

• 04589551388929 - VA170LUX-SC: 2026-02-23
• 04589551388936 - VA170-SC: 2026-02-23
• 04589551388981 - Potentiometer Set: 2026-02-23
• 04589551389452 - Varios: 2026-02-23
• 04589551383900 - Varios: 2026-02-23
• 04589551389476 - Perio Kit A: 2026-02-23
• 04589551389483 - VA170: 2026-02-23
• 04560264577763 - VA2-LUX-HP Ti: 2026-02-23
• 04560264577763 - VA2-LUX-HP Ti: 2026-02-23