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FDA 510(k)

PMMA Blocks for Dental Use

K-Number: K223477 · 2023-02-16

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2023-02-16
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PMMA Blocks for Dental Use is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K223477. 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 Blocks for Dental Use?

PMMA Blocks for Dental Use is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K223477.

When did PMMA Blocks for Dental Use receive FDA 510(k) clearance?

PMMA Blocks for Dental Use received FDA 510(k) clearance on 2023-02-16, under 510(k) number K223477.

Who is the listed applicant for PMMA Blocks for Dental Use?

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

What is the FDA product code for PMMA Blocks for Dental Use?

The FDA product code for PMMA Blocks for Dental Use is EBG.

Other records listing Aidite (Qinhuangdao) Technology Co., Ltd. as applicant

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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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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