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Dental Impression Material

by Nanchang Dental Bright Technology Co., Ltd.

510(k) K211489

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 NumberK211489 Date28 Jul 2021ClearedStatusActive

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  • Withdrawn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, 28 Sep 2026

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

Dental Impression Material is a Class II medical device used to create accurate molds of teeth and oral tissues for dental applications. The material is designed to capture detailed impressions of dental structures for use in various dental procedures.

This device is supplied by Nanchang Dental Bright Technology Co., Ltd. and is authorized under FDA 510K clearance with product code ELW. The material is regulated under 872.3660 and is intended for dental use, though specific sterility, single-use or reusable status, MRI safety, and storage details are not provided in the data.

Questions

AI-generated answers, 28 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 Dental Impression Material used for?

    The Dental Impression Material is a Class II medical device used to create accurate molds of teeth and oral tissues for various dental applications. It captures detailed impressions of dental structures to be used in dental procedures requiring precise models.

  • What is the regulatory status of this Dental Impression Material?

    This device is authorized under FDA 510K clearance with product code ELW. It is regulated under 872.3660 and was determined to be substantially equivalent through a traditional clearance process by the Dental advisory committee.

  • Is the Dental Impression Material single-use or reusable?

    The device data does not specify whether the Dental Impression Material is single-use or reusable. This information would need to be obtained directly from the manufacturer or product documentation as it's not provided in the regulatory data.

  • Who manufactures the Dental Impression Material?

    The Dental Impression Material is supplied by Nanchang Dental Bright Technology Co., Ltd., located in Nanchang, China. The company received FDA 510K clearance for this device on July 28, 2021.