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

Devices Manufactured by HU-FRIEDY MFG. CO., LLC

• 10889950146221 - Hu-Friedy: 2025-04-10 Hinged Statim, 12-inst, Red, NH, AW
• 10889950146238 - Hu-Friedy: 2025-04-10 5.5 x 8, Red, 4 Elev/ACC Area
• 10889950146245 - Hu-Friedy: 2025-04-10 10, Instr, Green, All LP
• 10889950146214 - Hu-Friedy: 2025-04-02 MTO INFIN 14 INST DD CASS,LVNDR,SS,AW,NH
• 10889950146115 - Hu-FriedyGroup: 2025-04-01 S3 Probe, single ended, #6 handle
• 10889950146122 - Hu-FriedyGroup: 2025-04-01 S3 Probe, single ended, smooth handle
• 10889950146139 - Hu-FriedyGroup: 2025-04-01 S3 Probe with #23 explorer, #6 handle
• 10889950003050 - HU-FRIEDY: 2025-03-05 Amalgam Carrier DE Regular/Large