KCL-LED

GUDID 04560264568655

NAKANISHI INC.

Pneumatic dental handpiece coupler

• Primary Device ID: 04560264568655
• NIH Device Record Key: ca3b5de3-29df-4f63-8b0f-6edbf7a4e881
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KCL-LED
• Version Model Number: KCL-LED
• 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	04560264568471 [Primary]
GS1	04560264568655 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203791

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

[04560264568655]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-01
• Device Publish Date: 2022-10-24

Devices Manufactured by NAKANISHI INC.

• 04589551365197 - Primado2: 2025-02-17
• 04589551365234 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551365241 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551365258 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551365265 - NSK Sterile Burs/Drills: 2025-02-17
• 04589551391127 - Perio-Mate: 2025-02-12
• 04589551391134 - Perio-Mate: 2025-02-12
• 04589551391141 - Perio-Mate: 2025-02-12