Solventum US LLC EX-1123833

GUDID 00197998465239

Solventum™ EX-1123833 Matrix

Solventum US LLC

Dental matrix band, single-use

• Primary Device ID: 00197998465239
• NIH Device Record Key: e07183a1-c03a-48ac-9da1-54d3c173def6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum US LLC
• Version Model Number: EX-1123833
• Catalog Number: EX-1123833
• Company DUNS: 119004140
• Company Name: Solventum US LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998465239 [Primary]

FDA Product Code

• KCQ: TUBE IMPRESSION AND MATRIX

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: 2025-07-08
• Device Publish Date: 2025-06-30

Devices Manufactured by Solventum US LLC

• 00197998465239 - Solventum US LLC: 2025-07-08Solventum™ EX-1123833 Matrix
• 00197998465239 - Solventum US LLC: 2025-07-08 Solventum™ EX-1123833 Matrix
• 10605861087121 - Filtek Three Shade Flowable Restorative: 2024-12-19 Unlabelled Bright Chameleon Flow Syringe 2G
• 10605861087138 - Filtek Three Shade Flowable Restorative: 2024-12-19 Unlabelled Natural Chameleon Flow Syringe 2G
• 10605861087145 - Filtek Three Shade Flowable Restorative: 2024-12-19 Unlabelled Warm Chameleon Flow Syringe 2G