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FDA 510(k)

Additively Manufactured Denture Resin

K-Number: K242884 · 2024-11-22

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2024-11-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Additively Manufactured Denture Resin 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 2024-11-22 under 510(k) number K242884. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additively Manufactured Denture Resin?

Additively Manufactured Denture Resin is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K242884.

When did Additively Manufactured Denture Resin receive FDA 510(k) clearance?

Additively Manufactured Denture Resin received FDA 510(k) clearance on 2024-11-22, under 510(k) number K242884.

Who is the listed applicant for Additively Manufactured Denture Resin?

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 Additively Manufactured Denture Resin?

The FDA product code for Additively Manufactured Denture Resin is EBI.

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.

K253036Light-curing Coloring Materials (ALCM)K251415Additively Manufactured Aligner ResinK250534Biomic Color OpaqueK250497Additive Manufacturing (Light Curing) Crown Bridge ResinK250811Dental Zirconia CeramicK250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )

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Related Devices (Code: EBI)

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.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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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