Expose

GUDID 00817051021744

Expose Blue Indicator Kit

CENTRIX, INC.

Dental caries detecting stain

• Primary Device ID: 00817051021744
• NIH Device Record Key: b917a1be-c293-46b6-8a24-f24951a0d2be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Expose
• Version Model Number: 310322
• 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: true
• 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	00817051021744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963927

FDA Product Code

• LFC: Device, Caries Detection

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: 2024-01-01
• Device Publish Date: 2023-12-22

On-Brand Devices [Expose]

• 00817051022369: Expose Refill Red Fine
• 00817051022352: Expose Refill Red XF
• 00817051022345: Expose Refill Blue XF
• 00817051022338: Expose Refill Blue Fine
• 00817051021744: Expose Blue Indicator Kit
• 00817051021706: Expose Refill Blue Fine
• 00817051021690: Expose Refill Blue XF