Expose

GUDID 00817051021690

Expose Refill Blue XF

CENTRIX, INC.

Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain Dental caries detecting stain

• Primary Device ID: 00817051021690
• NIH Device Record Key: 8c75b9a6-fb3b-4f88-a040-285f3ecff218
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Expose
• Version Model Number: 310335
• 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	00817051021690 [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