Solventum™ Vitrebond™ EX-1087333

GUDID 00197998302732

Solventum™ Vitrebond™ Pulp Protect Liner/Base, EX-1087333

Solventum US LLC

Glass ionomer dental cement

• Primary Device ID: 00197998302732
• NIH Device Record Key: d9c6259c-e7e5-40f9-808d-88984e6e410b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Vitrebond™
• Version Model Number: EX-1087333
• Catalog Number: EX-1087333
• Company DUNS: 119004140
• Company Name: Solventum US LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• 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
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998302732 [Primary]

FDA Product Code

• EJK: LINER, CAVITY, CALCIUM HYDROXIDE

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: 2025-10-07
• Device Publish Date: 2025-09-29

Devices Manufactured by Solventum US LLC

• 00197998014789 - Solventum™ Transpore™: 2026-02-23 Solventum™ Transpore™ White Surgical Tape, 1534-0, 1,25 cm x 9,1 m (0.5IN/PO x 10 YD/V), 24/CAR
• 00197998014871 - Solventum™ Transpore™: 2026-02-23 Solventum™ Transpore™ White Surgical Tape, 1534-3, 7,6 cm x 9,1 m (3IN/PO x 10 YD/V), 4/CAR
• 00197998018916 - Solventum™ Transpore™: 2026-02-23 Solventum™ Transpore™ White Surgical Tape, 1534-1, 2,5 cm x 9,1 m (1IN/PO x 10 YD/V), 12/CAR
• 00197998018978 - Solventum™ Transpore™: 2026-02-23 Solventum™ Transpore™ White Surgical Tape, 1534-2, 5 cm x 9,1 m (2 IN/POx 10 YD/V), 6/CAR
• 00197998021985 - Solventum™ Medipore™: 2026-02-23 Solventum™ Medipore™ +Pad Soft Cloth Adhesive Wound Dressing, 3568, 15 x 15 cm (6 x 6 in), Pad - 10 x 10 cm (4 x 4 in), 25/C
• 00197998023590 - Solventum™ Transpore™: 2026-02-23 Solventum™ Transpore™ White Surgical Tape, 1534S-1, 2,5 cm x 1,3 m (1IN/PO x 1.5 YD/V), 100/CAR
• 00197998023750 - Solventum™ Medipore™: 2026-02-23 Solventum™ Medipore™ +Pad Soft Cloth Adhesive Wound Dressing, 3564, 6 x 10 cm (2.375 x 4 in), Pad - 2,5 x 6 cm (1 x 2.375 in
• 00197998023781 - Solventum™ Medipore™: 2026-02-23 Solventum™ Medipore™ +Pad Soft Cloth Adhesive Wound Dressing, 3569, 9 x 15 cm (3.5 x 6 in), Pad - 4,5 x 10 cm (1.75 x 4 in),