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

• 00197998302732 - Solventum™ Vitrebond™: 2025-10-07Solventum™ Vitrebond™ Pulp Protect Liner/Base, EX-1087333
• 00197998302732 - Solventum™ Vitrebond™: 2025-10-07 Solventum™ Vitrebond™ Pulp Protect Liner/Base, EX-1087333
• 00197998175251 - Solventum™ Promogran™: 2025-09-30 Solventum™ Promogran™ Collagen Matrix with ORC, M772028, 4.34 in2 (28 cm2), Hexagon, 10/CAR, 4 CAR/CS, 40/CS
• 00197998275364 - Solventum™ Promogran™: 2025-09-30 Solventum™ Promogran™ Collagen Matrix with ORC, PG004, Hexagon, 4.34 in2 (28 cm2), 10/CAR, 4 CAR/CS, 40/CS
• 00197998275401 - Solventum™ Promogran™: 2025-09-30 Solventum™ Promogran™ Collagen Matrix with ORC, PG019, Hexagon, 19.1 in2 (123 cm2), 10/CAR, 4 CAR/CS, 40/CS
• 00197998275524 - Solventum™ Promogran™: 2025-09-30 Solventum™ Promogran™ Collagen Matrix with ORC, M772123, Hexagon, 19.1 in2 (123 cm2), 10/CAR, 4 CAR/CS, 40/CS
• 00197998326905 - Solventum™ Nu-Gel™: 2025-09-30 Solventum™ Nu-Gel™ Hydrogel with Alginate, MNG415, 0.52 oz (15 g), 10/CAR, 4 CAR/CS, 40/CS
• 00197998326981 - Solventum™ Nu-Gel™: 2025-09-30 Solventum™ Nu-Gel™ Hydrogel with Alginate, MNG425, 0.88 oz (25 g), 6/CAR, 4 CAR/CS, 24/CS
• 00197998344992 - Solventum™ Filtek™: 2025-09-15 Solventum™ Filtek™ Easy Match Flowable Restorative, 6125B, 2 g, Syringe, 2/KT, 10/CS