3M Filtek Supreme Flowable Restorative

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K221695 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from 3M Espe AG Dental Products →

• What is the 3M Filtek Supreme Flowable Restorative used for?

  This dental restorative material is designed for a wide range of indications and techniques, including injection molding. It offers long-lasting wear resistance and polish retention, making it suitable for various dental applications.

• How is the Filtek Supreme Flowable Restorative supplied?

  The device is supplied as a flowable composite in a syringe that enables precise placement without bubbles or run-on. This delivery system helps clinicians achieve optimal results during dental procedures.

• What regulatory approvals does the Filtek Supreme Flowable Restorative have?

  The device has received FDA 510(k) clearance with the product code EBF. It is transitioning to Solventum Filtek Supreme Flowable Restorative, indicating a change in manufacturer while maintaining the same product specifications.

• Is the Filtek Supreme Flowable Restorative single-use or reusable?

  The device is a flowable composite restorative material that is typically used in single applications during dental procedures. It is not designed for reuse, as sterility and material integrity are maintained for each application.