Filtek Three Shade Flowable Restorative EXD-947167

GUDID 10605861087138

Unlabelled Natural Chameleon Flow Syringe 2G

Solventum US LLC

Dental composite resin

• Primary Device ID: 10605861087138
• NIH Device Record Key: c9bbf0b4-963a-4186-bd88-0404b706e6da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filtek Three Shade Flowable Restorative
• Version Model Number: EXD-947167
• Catalog Number: EXD-947167
• 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: true
• 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)634-2249
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)634-2249
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)634-2249
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)634-2249
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10605861087138 [Primary]

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: 2024-12-19
• Device Publish Date: 2024-12-11

On-Brand Devices [Filtek Three Shade Flowable Restorative]

• 10605861087145: Unlabelled Warm Chameleon Flow Syringe 2G
• 10605861087138: Unlabelled Natural Chameleon Flow Syringe 2G
• 10605861087121: Unlabelled Bright Chameleon Flow Syringe 2G