FLASH pearl

GUDID 04589551382774

NAKANISHI INC.

Dental abrasive powder Dental abrasive powder Dental abrasive powder Dental abrasive powder Dental abrasive powder Dental abrasive powder Dental abrasive powder Dental abrasive powder Dental abrasive powder Dental abrasive powder 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