Solventum™ Filtek™

Basic Information

• Brand Name: Solventum™ Filtek™
• Primary DI: 00197998102608
• Version / Model: 6520H
• Catalog Number: 6520H
• Company Name: Solventum Germany GmbH
• Labeler DUNS: 315518329
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-03
• Public Version: 2
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: faf2bc95-d62a-468d-b643-f10c60a5f7e0

Device Description

Solventum™ Filtek™ Composite Warmer Holder, 6520H, Holder Assembly Replacement

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QGO	Composite resin warmer	Dental	872.6100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65223	Dental material heater	An electrically-powered device designed to be used to heat, through conduction, a variety of materials/substances (e.g., composite resin, root canal cleaning solution, local anaesthetic agent) to facilitate application of the material (e.g., optimum performance, patient comfort) during a dental procedure. It consists of a heating element with a temperature controller and a heater plate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00197998102608	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]