Visible Light Cure Composite Dental Restorative Material

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

Full name

American Dental Products (Adp), Visible Light Cure Composite Dental Restorative Material

510(k) Number

K951426 ↗

FDA Product Code

EBF

FDA applicant

American Dental Products, Inc.

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 American Dental Products Inc →

• What is the American Dental Products (ADP) visible light cure composite used for?

  This composite dental restorative material is designed specifically for filling and restoring dental cavities. It provides durable, aesthetically pleasing repairs that closely match the natural color of teeth. The material hardens when exposed to visible light, allowing precise placement and shaping during dental procedures, making it ideal for restoring tooth structure and function.

• How is the ADP visible light cure composite supplied and prepared for use?

  The material is supplied as a single-use product, meaning each application requires a new unit. It is not sterile at the time of supply, so it must be prepared and applied by trained dental professionals in a clinical setting. Proper handling and preparation are essential to ensure optimal performance and patient safety.

• Is the ADP visible light cure composite intended for single-use or reuse?

  This composite is explicitly designed for single-use only. Each unit is meant to be used once and then discarded. This ensures sterility and consistency in clinical applications, as reuse could compromise the material’s integrity and increase infection risks.

• What storage conditions should be followed for the ADP visible light cure composite?

  While specific storage conditions are not detailed in the provided data, standard dental material handling practices should be followed to maintain the material’s integrity. This typically includes storing it in a cool, dry place, away from direct sunlight or extreme temperatures, and ensuring it is sealed properly to prevent contamination.

• What regulatory approval does the ADP visible light cure composite hold?

  The device holds FDA 510(k) clearance under the classification of a Class II medical device, with the clearance number K951426. This approval indicates that it has been deemed substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for visible light-cure composite dental restoratives.