Perio-Mate

GUDID 04589551391127

NAKANISHI INC.

Dental abrasive air jet system handpiece

• Primary Device ID: 04589551391127
• NIH Device Record Key: 41aaddc2-b243-49a2-bc95-b3b28a40e9dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perio-Mate
• Version Model Number: PER-PTL-P
• 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	04589551391127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241880

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

[04589551391127]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-12
• Device Publish Date: 2025-02-04

On-Brand Devices [Perio-Mate]

• 04589551391141: PER-M4-P
• 04589551391134: PER-KV-P
• 04589551391127: PER-PTL-P