Solventum™ Filtek™ 6125K

GUDID 00197998345319

Solventum™ Filtek™ Easy Match Flowable Restorative Intro Kit, 6125K, 2 g, Syringe, 3/KT, 12/CS

Solventum US LLC

Dental composite resin

• Primary Device ID: 00197998345319
• NIH Device Record Key: bc71ccc1-a4e1-4291-a717-8a23039e2761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Filtek™
• Version Model Number: 6125K
• Catalog Number: 6125K
• Company DUNS: 119004140
• Company Name: Solventum US LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998345302 [Primary]
GS1	00197998345319 [Package]; Contains: 00197998345302; Package: CASE [12 Units]; In Commercial Distribution

FDA Product Code

• EBF: Material, tooth shade, resin

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: 2025-09-15
• Device Publish Date: 2025-09-05

On-Brand Devices [Solventum™ Filtek™]

• 00197998345319: Solventum™ Filtek™ Easy Match Flowable Restorative Intro Kit, 6125K, 2 g, Syringe, 3/KT, 12/
• 00197998345173: Solventum™ Filtek™ Easy Match Flowable Restorative, Sample, 6125S, 1 g, Syringe, N, 1/KT,
• 00197998345036: Solventum™ Filtek™ Easy Match Flowable Restorative, 6125W, 2 g, Syringe, 2/KT, 10/CS
• 00197998345012: Solventum™ Filtek™ Easy Match Flowable Restorative, 6125N, 2 g, Syringe, 2/KT, 10/CS
• 00197998344992: Solventum™ Filtek™ Easy Match Flowable Restorative, 6125B, 2 g, Syringe, 2/KT, 10/CS