Matrix® Strip 031000300

GUDID D8130310003000

MATRIX STRIPS SLV DDS

DEN-MAT HOLDINGS, LLC

Dental matrix band retainer

• Primary Device ID: D8130310003000
• NIH Device Record Key: c899f0a6-9713-43bd-8567-cf69bd0d3be6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Matrix® Strip
• Version Model Number: 031000300
• Catalog Number: 031000300
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, 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: 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: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130310003000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K772316

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2022-09-30
• Device Publish Date: 2022-09-22

Devices Manufactured by DEN-MAT HOLDINGS, LLC

• D81394000WTYH0 - Rotadent: 2025-02-27 RD PROCARE WTY HANDLE
• 03598833235166 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE ENW SYR
• 03598833235265 - EVANESCE: 2025-01-07 EVANESCE EVANESCE INJECTABLE
• 03598833235272 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A2U SYR
• 03598833235289 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE B1U SYR
• 03598833235296 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE BL1U SYR
• 03598833235302 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A3U SYR
• 00359883973216 - EVANESCE: 2024-12-23 EVANESCE BULK CURE A2 SY 1x3g