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FDA 510(k)

PMMA Block

K-Number: K201683 · 2020-11-03

ApplicantHuge Dental Material Co., Ltd.
Decision Date2020-11-03
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PMMA Block is the device name listed in this FDA 510(k) record. The listed applicant is Huge Dental Material Co., Ltd.. It received FDA 510(k) clearance on 2020-11-03 under 510(k) number K201683. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMMA Block?

PMMA Block is a medical device that received FDA 510(k) clearance on 2020-11-03. The listed applicant is Huge Dental Material Co., Ltd.. The 510(k) number is K201683.

When did PMMA Block receive FDA 510(k) clearance?

PMMA Block received FDA 510(k) clearance on 2020-11-03, under 510(k) number K201683.

Who is the listed applicant for PMMA Block?

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

What is the FDA product code for PMMA Block?

The FDA product code for PMMA Block is EBG.

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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