Capture Impression Material

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

510(k) Number

K943574 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Dentsply Intl. →

• What is the Capture Impression Material used for in dentistry?

  The Capture Impression Material is designed to create highly detailed and accurate impressions of teeth and surrounding tissues. These impressions are essential for fabricating dental prosthetics such as crowns, bridges, and dentures, ensuring a precise fit and optimal functionality for the patient.

• How is the Capture Impression Material supplied, and what sizes are available?

  The Capture Impression Material is supplied in various formulations, each corresponding to specific registration numbers (e.g., 3004425647, 3008582406). These formulations cater to different clinical needs, and the material comes in multiple sizes to accommodate diverse dental procedures. The exact sizes are tied to the registration numbers listed in the FDA database.

• Is the Capture Impression Material sterile, and how should it be prepared for use?

  The Capture Impression Material is non-sterile as supplied. Before clinical use, it must be sterilized or prepared appropriately according to standard dental protocols to ensure patient safety and infection control. Follow manufacturer guidelines for sterilization methods.

• Can the Capture Impression Material be reused, or is it intended for single-use?

  The Capture Impression Material is explicitly intended for single-use applications in clinical settings. Reuse is not recommended, as it may compromise accuracy, detail capture, and patient safety. Each impression should be discarded after use.

• How should the Capture Impression Material be stored, and what are its regulatory requirements?

  The Capture Impression Material should be stored in a clean, dry environment, protected from extreme temperatures and direct sunlight, as per the manufacturer’s instructions. Regulatory compliance is ensured under FDA 510(k) clearance (K943574) and classified as Class II under special controls, adhering to regulation 872.3660. Always refer to the latest labeling for storage specifics.