Solventum™ Filtek™ 12012014

GUDID 00197998327667

Solventum™ Filtek™ Composite Warmer Kit, 100-240V NA

TOP-Service für Lingualtechnik GmbH

Dental material heater

• Primary Device ID: 00197998327667
• NIH Device Record Key: 77ef1585-be1c-46fa-b70f-a872cc19a4b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Filtek™
• Version Model Number: 12012014
• Catalog Number: 12012014
• Company DUNS: 315518329
• Company Name: TOP-Service für Lingualtechnik 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)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)634-2249
• Email: regulatoryrequests@solventum.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998327667 [Primary]

FDA Product Code

• QGO: Composite resin warmer

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: 2025-04-11
• Device Publish Date: 2025-04-03