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VPS Impression Material

by Hygedent, Inc. 2 variants

510(k) K191034

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 NumberK191034 Date4 Sep 2019ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The VPS Impression Material is a vinyl polysiloxane (VPS) addition-curing elastomeric precision impression material designed for dental applications. It captures detailed and accurate impressions of oral structures, facilitating the fabrication of dental prosthetics, crowns, bridges, and orthodontic appliances with high fidelity and dimensional stability.

This material is supplied in cartridges (e.g., 2–50 ml) with mixing tips for on-demand dispensing, ensuring consistent viscosity and handling. It is intended for single-use in clinical settings, with a working time of approximately 2 minutes, a time in mouth of 2 minutes 30 seconds, and a set time of 4 minutes 30 seconds. The product adheres to FDA 510(k) clearance (K191034) under the Dental Device classification (Class II, regulation number 872.3660) and is manufactured in compliance with international standards.

Other devices from Hygedent, Inc.

Questions

AI-generated answers, 19 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 VPS Impression Material used for?

    The VPS Impression Material is designed to capture detailed and accurate impressions of oral structures, facilitating the fabrication of dental prosthetics, crowns, bridges, and orthodontic appliances with high fidelity and dimensional stability.

  • How is the VPS Impression Material supplied and dispensed?

    The material is supplied in cartridges ranging from 2 to 50 ml, equipped with mixing tips for on-demand dispensing, which ensures consistent viscosity and handling during clinical use.

  • Is the VPS Impression Material intended for single-use or reuse?

    The VPS Impression Material is intended for single-use in clinical settings, as specified in its description, to maintain hygiene and prevent cross-contamination between patients.

  • What are the working and setting times for the VPS Impression Material?

    The material has a working time of approximately 2 minutes, a time in mouth of 2 minutes 30 seconds, and a total set time of 4 minutes 30 seconds, allowing sufficient time for placement and accurate impression capture.

  • What regulatory pathway was used for the VPS Impression Material?

    The VPS Impression Material received FDA 510(k) clearance under submission number K191034, indicating it was found substantially equivalent to a legally marketed predicate device.