Dental Device Guide
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Manufacturer registered with FDA

Aidite (Qinhuangdao) Technology Co., Ltd

Qinhuangdao, China. Lists 14 dental device types with FDA across 1 registered establishment, and holds 16 510(k) clearances as applicant.

FDA owner/operator10038510Foreign exporterManufacturerRepacker / relabeler13 clearances in five years
Device types listed
14
Brands and models
39
510(k) clearances
162020–2026
Markets registered in
146,709 registrations outside the US
Establishments
1China
2020: 32022: 22023: 32024: 22025: 52026: 120102020

510(k) clearances per year, 2007–2026

Registered in 14 markets

Where regulators' registries name Aidite (Qinhuangdao) Technology Co., Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 14 device types listedEuropean Union: 6,562 registrationsAustralia: 36 registrationsCanada: 26 registrationsBrazil: 20 registrationsColombia: 20 registrationsTaiwan: 13 registrationsSouth Korea: 10 registrationsUnited Kingdom: 10 registrationsJapan: 4 registrationsPeru: 3 registrationsCosta Rica: 2 registrationsSerbia: 2 registrationsSaudi Arabia: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAidite (Qinhuangdao) Technology Co., Ltd16 clearances2020–2026Below
European UnionEUDAMEDManufacturerAidite（Qinhuangdao）Technology Co.,Ltd.6,562—Pure Global AI
AustraliaTGAManufacturerAidite (Qinhuangdao) Technology Co Ltd362013–2026Pure Global AI
CanadaHealth CanadaRegistration holderAIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD.262022–2026Pure Global AI
BrazilANVISAManufacturerAIDITE (QINHUANGDAO) TECHNOLOGY CO. LTD202020–2026Pure Global AI
ColombiaINVIMARegistration holderAIDITE (QINHUANGDAO) TECHNOLOGY CO., LTDAIDITE (QINHUANGDAO) TECHNOLOGY CO LTD · AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD. · +120—Pure Global AI
TaiwanTFDAManufacturerAidite (Qinhuangdao) Technology Co., Ltd.132015–2026Pure Global AI
South KoreaMFDSManufacturerAidite (Qinhuangdao) Technology Co., LtdAidite (Qinhuangdao) Technology Co., Ltd.102014–2026Pure Global AI
United KingdomMHRAManufacturerAidite (Qinhuangdao) Technology Co Ltd10—Pure Global AI
JapanPMDARegistration holderＡｉｄｉｔｅ（Ｑｉｎｈｕａｎｇｄａｏ）　Ｔｅｃｈｎｏｌｏｇｙ　Ｃｏ．，　Ｌｔｄ．42026–2026Pure Global AI
PeruDIGEMIDManufacturerAIDITE (QINHUANGDAO) TECHNOLOGY Co., Ltd.32019–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerAidite (Qinhuangdao) Technology Co., Ltd.2—Pure Global AI
SerbiaALIMSManufacturerAidite (Qinhuangdao) Technology Co., Ltd.22025–2025Pure Global AI
Saudi ArabiaSFDAManufacturerAidite (Qinhuangdao) Technology Co. Ltd1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Aidite (Qinhuangdao) Technology Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Porcelain PowderEIH · Class 2Dental ceramics & zirconiaMaker
AiditeBiomic Color OpaqueDental Crystallized Ceramics (HT,LT,ST)Dental Zirconia CeramicMultilayer-3DMultilayer-3DproPorcelain Powder For Clinical UseSHT-APMSHT-PRE-TUTC
1 more
UTM
2020
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
Additive Manufacturing (Light Curing) Crown Bridge ResinDental Ceramic BlocksFREEPRINT crownLight-curing Coloring Materials (ALCM)3D Printing Material Crown Bridge
2023
Resin Temporary Crown and BridgeEBG · Class 2Temporary crown & bridge materialsMaker
Additive Manufacturing (Light Curing) Crown Bridge ResinFREEPRINT crownPMMA Blocks for Dental Use3D Printing Material Crown Bridge3D Printing Material Temp
2023
Rebasing Repairing Relining Denture ResinEBI · Class 2Denture resins & teethMaker
Additively Manufactured Denture ResinDenture Base ResinFreeprint denture3D Printing Material Denture Base
2023
Resin Impression Tray MaterialEBH · Class 1Impression traysMaker
3D Printing Material Tryin3D Printing Try-in Material, APMR01
2017
Intraoral Dental WaxEGD · Class 1—Maker
Dental Casting3D Printing Cast Material
2017
Preformed Impression TrayEHY · Class 1Impression traysMaker
3D Printing Material Gingiva Model3D Printing Material Model
2019
Alloy Other Noble MetalEJS · Class 2Dental alloysMaker
Aidite Firing Paste
2019
Preformed Tooth PositionerKMY · Class 1Retainers, expanders & headgearMaker
3D Printing Material Splint
2024
Color ScannerKZN · Class 2—Maker
Intraoral Scannerlntraoral Scanner; Model: Rapid 3, Rapid 5, Infinity 5
2025
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
3D Printing Material Surgical Guide, Model: APMR02
2022
Sequential AlignerNXC · Class 2Clear alignersMaker
Additively Manufactured Aligner Resin
2025
Resin Long-Term Temporary Crown and BridgePOW · Class 2—Maker
Additive Manufacturing (Light Curing) Crown Bridge Resin
2025
Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2Denture resins & teethMaker
Additive Manufacturing (Light Curing) Crown Bridge Resin
2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Aidite (Qinhuangdao) Technology Co., Ltd as the applicant.

Decided510(k)DeviceDevice type
6 Apr 2026K253036Light-curing Coloring Materials (ALCM)EBF Resin Tooth Shade Material
27 Aug 2025K251415Additively Manufactured Aligner ResinNXC Sequential Aligner
20 May 2025K250534Biomic Color OpaqueEIH Porcelain Powder
30 Apr 2025K250497Additive Manufacturing (Light Curing) Crown Bridge ResinEBF Resin Tooth Shade Material
11 Apr 2025K250811Dental Zirconia CeramicEIH Porcelain Powder
14 Mar 2025K250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )EIH Porcelain Powder
22 Nov 2024K242884Additively Manufactured Denture ResinEBI Rebasing Repairing Relining Denture Resin
12 Jul 2024K241715Dental Glass Ceramics Blocks (HT,LT,ST)EIH Porcelain Powder
17 Mar 2023K230115Denture Base ResinEBI Rebasing Repairing Relining Denture Resin
8 Mar 2023K223742Dental Ceramic BlocksEBF Resin Tooth Shade Material
16 Feb 2023K223477PMMA Blocks for Dental UseEBG Resin Temporary Crown and Bridge
6 Dec 2022K222626Dental Zirconia CeramicEIH Porcelain Powder
7 Jan 2022K213570Dental Zirconia CeramicEIH Porcelain Powder
17 Dec 2020K190217Aidite PMMAEBG Resin Temporary Crown and Bridge
18 Aug 2020K192723Coloring LiquidEIH Porcelain Powder
8 Jul 2020K192231Dental Glass Ceramics BlocksEIH Porcelain Powder

Some of these clearances are listed with FDA today by another company: CAO Group, Inc. (1), Hunan Vsmile Biotechnology Co.,Ltd (1).

Also lists devices cleared under other names

Aidite (Qinhuangdao) Technology Co., Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Detax GmbH & Co. KG (2), Detax GmbH (1).

Decided510(k)DeviceApplicantDevice type
23 Sep 2022K222877FREEPRINT crownDetax GmbHEBF Resin Tooth Shade Material
16 Nov 2020K200461Freeprint dentureDetax GmbH & Co. KGEBI Rebasing Repairing Relining Denture Resin
27 Oct 2020K200273FREEPRINT tempDetax GmbH & Co. KGEBG Resin Temporary Crown and Bridge

Registered establishments

EstablishmentLocationWhat it does
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTDFDA reg. 3009482106Qinhuangdao City Hebei, ChinaForeign exporter, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10038510). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.