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Hygedent Alginate Impression Material

by Hygedent, Inc.

510(k) K140074

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140074 Date21 May 2014ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ELW
Device Class
Class II
Regulation
21 CFR Part 872.3660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Hygedent Alginate Impression Material is a dental impression material used to create impressions of the oral cavity. It is a dustless powder that, when mixed, forms a material with a creamy consistency, high tear resistance, and elastic properties suitable for general dental practice and orthodontics.

This device is supplied as a powder and is regulated under FDA 510(k) authorization. It is intended for use in dental settings by professionals. Users should refer to the manufacturer's instructions for storage and handling to maintain its performance specifications.

Other devices from Hygedent, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of Hygedent Alginate Impression Material?

    This material is intended for use by dental professionals to create impressions of the oral cavity. It is suitable for applications in general dental practice and orthodontics.

  • How is this impression material supplied?

    The device is supplied as a dustless powder. When mixed, it forms a material with a creamy consistency that provides high tear resistance and elastic properties.

  • What are the storage and handling requirements?

    Users should refer to the manufacturer's specific instructions for storage and handling. Following these guidelines is necessary to maintain the performance specifications of the material.

  • Is this device regulated?

    Yes, this device is regulated under FDA 510(k) authorization. It is classified under regulation number 872.3660.