Z99L

GUDID 04589551391592

NAKANISHI INC.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 04589551391592
• NIH Device Record Key: b97f1af8-8656-472b-bd13-f20e29766a4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z99L
• Version Model Number: Z99L
• 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	04589551391585 [Primary]
GS1	04589551391592 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202960

FDA Product Code

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

Sterilization

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

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

[04589551391592]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-29
• Device Publish Date: 2025-05-21

Devices Manufactured by NAKANISHI INC.

• 04589551391592 - Z99L: 2025-05-29
• 04589551391592 - Z99L: 2025-05-29
• 04589551392667 - Tip Remover: 2025-05-26
• 04560264523913 - Ring Wrench: 2025-03-31
• 04560264524019 - Cleaning Wire: 2025-03-31
• 04560264524026 - Cleaning Wire: 2025-03-31
• 04560264524033 - Cleaning File: 2025-03-31
• 04560264524040 - Cleaning Brush: 2025-03-31
• 04560264546158 - Nozzle Tip Remover: 2025-03-31