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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 the device name listed in this FDA 510(k) record. The listed applicant is Nanchang Dental Bright Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) 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. The listed applicant is Nanchang Dental Bright Technology Co., Ltd.. The 510(k) number is K211489.

When did Dental Impression Material receive FDA 510(k) clearance?

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

Who is the listed applicant for Dental Impression Material?

The FDA 510(k) record lists Nanchang Dental Bright Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Impression Material?

The FDA product code for Dental Impression Material is ELW.

Related Devices (Code: ELW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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