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FDA 510(k)

Dental Impression Material

K-Number: K211489 · 2021-07-28

ApplicantNanchang Dental Bright Technology Co., Ltd.
Decision Date2021-07-28
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Impression Material is a medical device manufactured by Nanchang Dental Bright Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under approval number K211489. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Impression Material?

Dental Impression Material is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Nanchang Dental Bright Technology Co., Ltd.. The 510(k) number is K211489.

When was Dental Impression Material approved by the FDA?

Dental Impression Material received FDA 510(k) clearance on 2021-07-28, under approval number K211489.

What company makes Dental Impression Material?

Dental Impression Material is manufactured by Nanchang Dental Bright Technology Co., Ltd..

What is the FDA product code for Dental Impression Material?

The FDA product code for Dental Impression Material is ELW.

Related Clinical Trials

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Related PubMed Literature

PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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