Prophy-Mate neo

GUDID 04560264507166

NAKANISHI INC.

Dental abrasive air jet system handpiece

• Primary Device ID: 04560264507166
• NIH Device Record Key: 9bb997cb-0e93-4dd9-b9e3-5fcf52302809
• Commercial Distribution Discontinuation: 2022-09-23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prophy-Mate neo
• Version Model Number: PMNG-PTL
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	04560264507166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112673

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

[04560264507166]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-11
• Device Publish Date: 2022-08-03

On-Brand Devices [Prophy-Mate neo]

• 04560264572492: PMNG-KV
• 04560264572478: PMNG-M4
• 04560264572461: PMNG-PTL
• 04560264572454: PMN-HP
• 04589551383283: PMNG-M4-P
• 04560264507166: PMNG-PTL