ProGaurd™

GUDID 10889950134143

ProGuard Varnish Pack

HU-FRIEDY MFG. CO., LLC

Dental cavity varnish

• Primary Device ID: 10889950134143
• NIH Device Record Key: ef28a545-30da-4fee-b29b-97278cfc74b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGaurd™
• Version Model Number: SP-PGFV
• Company DUNS: 005085972
• Company Name: HU-FRIEDY MFG. CO., LLC
• 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: 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(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889950134143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080814

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: 2022-03-21
• Device Publish Date: 2022-03-11

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• 10889950146337 - Hu-Friedy: 2025-05-02 MTO 8X11 INFINITY CASS,PURPLE,4 INST,C12
• 10889950146344 - Hu-Friedy: 2025-05-02 MTO 8X11 INFINITY CASS,BLUE,4 INST,C12
• 10889950146351 - Hu-Friedy: 2025-05-02 MTO 8X11 INFINITY CASS,GREEN,4 INST,C12