Solventum™ Filtek™ 6520H

GUDID 00197998102608

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

Solventum Germany GmbH

Dental material heater

• Primary Device ID: 00197998102608
• NIH Device Record Key: faf2bc95-d62a-468d-b643-f10c60a5f7e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Filtek™
• Version Model Number: 6520H
• Catalog Number: 6520H
• Company DUNS: 315518329
• Company Name: Solventum Germany GmbH
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: +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	00197998102608 [Primary]

FDA Product Code

• QGO: Composite resin warmer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-03-20
• Device Publish Date: 2025-11-03

On-Brand Devices [Solventum™ Filtek™]

• 00197998102615: Solventum™ Filtek™ Composite Warmer Silicone Sleeve, 6520S, Silicone Sleeve Replacement
• 00197998102608: Solventum™ Filtek™ Composite Warmer Holder, 6520H, Holder Assembly Replacement
• 00197998102578: Solventum™ Filtek™ Composite Warmer, 6510K, 100-240V, Type A