Sparkle V Sodium Fluoride Varnish, Caramel

GUDID 50732224005565

Sodium Fluoride Varnish, Caramel

CROSSTEX INTERNATIONAL, INC.

Dental cavity varnish

• Primary Device ID: 50732224005565
• NIH Device Record Key: b3fed168-d104-4a1c-be1b-4b61c6726e60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sparkle V Sodium Fluoride Varnish, Caramel
• Version Model Number: UFVCA
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 120
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224005560 [Unit of Use]
GS1	10732224005567 [Primary]
GS1	50732224005565 [Package]; Contains: 10732224005567; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040098

FDA Product Code

• LBH: VARNISH, CAVITY

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: 2023-10-10
• Device Publish Date: 2023-10-02

Devices Manufactured by CROSSTEX INTERNATIONAL, INC.

• 00732224005508 - DentaPure 365-Day Independent Water Bottle Cartridge: 2024-09-16 Water Purification Bottle Cartridge
• 00732224005515 - DentaPure Water Purification Municipal Cartridge: 2024-09-16 Water Purification Municipal Cartridge
• 00732224005522 - DentaPure Water Purification Bottle Cartridge: 2024-09-16 Water Purification Bottle Cartridge
• 00732224005690 - Crosstex: 2024-04-29 Soft Adaptors for Hygoformic Saliva Ejectors
• 00732224721484 - Sporview 10 Hour Self Contained BI: 2024-04-18 For use in biologically monitoring steam sterilizers
• 20815878025321 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027585 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027592 - Burkhart Cotton Rolls: 2024-04-17