Skip to content

Hyunjae Dental Impression Materials

by Hyunjae Corp.

510(k) K962680

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 NumberK962680 Date30 Sep 1996ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

Hyunjae Dental Impression Materials are devices composed of materials such as alginate or polysulfide. They are intended to be placed on a preformed impression tray to reproduce the structure of a patient's teeth and gums.

This device is regulated under FDA 510(k) clearance K962680. It is classified as an impression material under regulation number 872.3660.

Other devices from Hyunjae Corp.

Questions

AI-generated answers, 26 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 are Hyunjae Dental Impression Materials used for?

    These materials are intended to be placed on a preformed impression tray to create an accurate reproduction of a patient's teeth and gums for dental procedures.

  • What is the composition of these impression materials?

    The devices are composed of dental impression materials such as alginate or polysulfide, which are standard substances used to capture detailed dental anatomy.

  • How is this device regulated?

    This device is regulated under FDA 510(k) clearance K962680 and is classified as an impression material under regulation number 872.3660.