Border-Lock® Green Mouldable Lower Dentulous Tray #57 187457

GUDID 00359883006990

Dental impression tray, single-use

DEN-MAT HOLDINGS, LLC

Dental impression tray, single-use

• Primary Device ID: 00359883006990
• NIH Device Record Key: 1a01f2c1-7638-425c-a429-332625bef9b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Border-Lock® Green Mouldable Lower Dentulous Tray #57
• Version Model Number: 187457
• Catalog Number: 187457
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883006990 [Primary]

FDA Product Code

• EHY: TRAY, IMPRESSION, PREFORMED

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: 2025-03-20
• Device Publish Date: 2025-03-12

Devices Manufactured by DEN-MAT HOLDINGS, LLC

• 00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack: 2025-03-26 Gingival Retraction Solution
• 00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit: 2025-03-26 Gingival Retraction Solution
• 00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack: 2025-03-24 VPS Impression Material
• 00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack: 2025-03-21 Wheel, Polishing Agent
• 00359883006501 - Clinician's Choice® G5 Sample Pack: 2025-03-21 Dental coating, tooth-desensitizing, professional
• 00359883000608 - PowerMix™ Automatic Impression Material Dispenser: 2025-03-20 Two-component dental material applicator, electric
• 00359883000615 - PowerMix™ Dynamic Mixing Tips: 2025-03-20 Dental material mixing nozzle, non-sterile
• 00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange: 2025-03-20 Device to engage the matrices and separate teeth