Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material

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

510(k) Number

K021416 ↗

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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• What is Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material used for?

  It is designed for use in dental applications to capture fine details with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation when making dental impressions.

• How is Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material supplied?

  The material is supplied as a dental impression material, though the specific format (e.g., cartridges, tubes, kits) is not detailed in the provided data.

• Is Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material sterile or single-use?

  The data provided does not indicate whether the material is sterile, single-use, or reusable; no information on sterility or reuse status is included in the device specifications.

• What regulatory pathway was used for Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material?

  It is regulated under FDA 510(k) clearance (K021416) as a Class II device, determined to be substantially equivalent to a legally marketed predicate device.