SilverSense

GUDID 00817051023625

SilverSense Clinic Kit

CENTRIX, INC.

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• Primary Device ID: 00817051023625
• NIH Device Record Key: 8258c566-e94e-4574-a19f-8e7f4146b1c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SilverSense
• Version Model Number: 310173
• Company DUNS: 053707303
• Company Name: CENTRIX, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00817051023625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222459

FDA Product Code

• PHR: Diammine Silver Fluoride Dental Hypersensitivity Varnish

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: 2023-12-21
• Device Publish Date: 2023-12-13

On-Brand Devices [SilverSense]

• 00817051023632: SilverSense Standard Kit
• 00817051023625: SilverSense Clinic Kit