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Data / Medical devices / China / Aidite (qinhuangdao) Technology Co., Ltd

Aidite (qinhuangdao) Technology Co., Ltd: FDA-registered device maker in Qinhuangdao City Hebei, China, 17 510(k) clearances

Aidite (qinhuangdao) Technology Co., Ltd is registered with the FDA (registration 3009482106) in Qinhuangdao City Hebei, China. It lists 16 device types. The FDA files 17 510(k) clearances under its listings, the newest dated April 6, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Aidite (qinhuangdao) Technology Co., Ltd
FDA registration number
3009482106
Address
No.56 Tianchi Road & No.9 Dushan Road, Economic and Technological Development Zone, Qinhuangdao City Hebei, China, 066004
Owner or operator
Aidite (Qinhuangdao) Technology Co., Ltd (10038510)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
July 17, 2017
Registered through
2026
Brand names listed
3D Printing Cast Material, 3D Printing Material Crown Bridge, 3D Printing Material Denture Base, 3D Printing Material Gingiva Model, 3D Printing Material Model, 3D Printing Material Splint, 3D Printing Material Surgical Guide, Model: APMR02, 3D Printing Material Temp and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture ToothPZY2Manufactureraccessdata.fda.gov
Aligner, SequentialNXC2Manufactureraccessdata.fda.gov
Alloy, Other Noble MetalEJS2Manufactureraccessdata.fda.gov
Crown And Bridge, Long-Term Temporary, ResinPOW2Manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Loupe, Binocular, Low PowerHJH1Manufactureraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Exporter to the US, Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufactureraccessdata.fda.gov
Mouthguard, PrescriptionMQCUManufactureraccessdata.fda.gov
Positioner, Tooth, PreformedKMY1Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Manufactureraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Manufactureraccessdata.fda.gov
Scanner, ColorKZN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Impression, PreformedEHY1Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 6, 2026K253036Light-curing Coloring Materials (ALCM)EBFSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
August 27, 2025K251415Additively Manufactured Aligner ResinNXCSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
May 20, 2025K250534Biomic Color OpaqueEIHSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
April 30, 2025K250497Additive Manufacturing (Light Curing) Crown Bridge ResinEBFSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
April 11, 2025K250811Dental Zirconia CeramicEIHSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
March 14, 2025K250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )EIHSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
November 22, 2024K242884Additively Manufactured Denture ResinEBISubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
July 12, 2024K241715Dental Glass Ceramics Blocks (HT,LT,ST)EIHSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
October 12, 2023K232448FREEPRINT® splintmasterMQCSubstantially EquivalentDetax GmbHaccessdata.fda.gov
March 17, 2023K230115Denture Base ResinEBISubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
March 8, 2023K223742Dental Ceramic BlocksEBFSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
February 16, 2023K223477PMMA Blocks for Dental UseEBGSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
December 6, 2022K222626Dental Zirconia CeramicEIHSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov
September 23, 2022K222877FREEPRINT crownEBFSubstantially EquivalentDetax GmbHaccessdata.fda.gov
November 16, 2020K200461Freeprint dentureEBISubstantially EquivalentDetax GmbH & Co. KGaccessdata.fda.gov
October 27, 2020K200273FREEPRINT tempEBGSubstantially EquivalentDetax GmbH & Co. KGaccessdata.fda.gov
August 18, 2020K192723Coloring LiquidEIHSubstantially EquivalentAidite (Qinhuangdao) Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated April 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.