E TIP WRENCH

GUDID 04589551382828

NAKANISHI INC.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 04589551382828
• NIH Device Record Key: af64ae6b-47f6-45e5-b7ea-7e598a314793
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E TIP WRENCH
• Version Model Number: E TIP WRENCH
• 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: true
• Serial Number: false
• 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	04589551382828 [Direct Marking]
GS1	04589551386710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113530

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

[04589551382828]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-29
• Device Publish Date: 2026-01-21

Devices Manufactured by NAKANISHI INC.

• 04589551387168 - Tip Cover L: 2026-01-29
• 04589551387151 - Tip Cover S: 2026-01-29
• 04589551382828 - E TIP WRENCH: 2026-01-29
• 04589551382828 - E TIP WRENCH: 2026-01-29
• 04589551387144 - Varios: 2026-01-29
• 04560264579958 - CLA-10: 2026-01-29
• 04589551388974 - 3 Mode Select Switch: 2026-01-29
• 04589551383863 - Varios: 2026-01-14
• 04589551383870 - Varios: 2026-01-14