Prisma-Fil

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K801732 ↗

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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  FDA 510(k) K982564 Active Cleared 6 Oct 1998

See all devices from Dentsply Intl. →

• What is Prisma-Fil used for?

  Prisma-Fil is a dental composite resin filling material specifically designed for restoring anterior (front) tooth structures. It is intended for direct restorative procedures to repair cavities, fractures, or other defects while matching the natural tooth shade and providing durable, aesthetically pleasing repairs. The material is formulated to blend seamlessly with the surrounding teeth, ensuring both function and appearance.

• How is Prisma-Fil supplied?

  Prisma-Fil is supplied as a single-use dental filling material, meaning each unit is intended for one clinical application only. This design ensures sterility and reduces the risk of cross-contamination between patients. The material is packaged for use in controlled clinical settings by dental professionals.

• Is Prisma-Fil reusable?

  No, Prisma-Fil is not designed for reuse. It is classified as a single-use dental composite resin filling material. Reusing dental materials can compromise sterility and the integrity of the restoration, so adhering to the single-use guideline is essential for safe and effective clinical practice.

• What regulatory clearance does Prisma-Fil hold?

  Prisma-Fil holds FDA 510(k) clearance under the Traditional review pathway, with the clearance number K801732. It is classified under product code EBF (Material, Tooth Shade, Resin) and is deemed substantially equivalent to a predicate device. This clearance confirms that the device meets FDA standards for safety and effectiveness as a dental composite resin filling material.

• Are there specific storage instructions for Prisma-Fil?

  The provided specifications do not detail specific storage instructions beyond standard dental material protocols. Generally, dental composite resins like Prisma-Fil should be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Always follow manufacturer guidelines and local regulations to maintain the material’s integrity and performance.