Perio Kit A

GUDID 04589551389476

NAKANISHI INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 04589551389476
• NIH Device Record Key: fae64c51-3319-4bfc-86b8-69ec2b8c3c84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perio Kit A
• Version Model Number: Perio Kit A
• 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	04589551389476 [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

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

Moist Heat or Steam Sterilization

[04589551389476]

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

On-Brand Devices [Perio Kit A]

• 04560264561717: Perio Kit A
• 04589551389476: Perio Kit A