FLASH pearl

GUDID 04589551382774

NAKANISHI INC.

Dental abrasive powder

• Primary Device ID: 04589551382774
• NIH Device Record Key: 3f3e7cb9-61c7-4023-a2ff-34d7b9b13a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLASH pearl
• Version Model Number: FLASH pearl
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	04560264513488 [Primary]
GS1	04589551382774 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112673

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

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 [FLASH pearl]

• 04560264574953: FLASH pearl
• 04589551382774: FLASH pearl