Aidite (Qinhuangdao) Technology Co., Ltd.
Manufacturer and brand owner in Qinhuangdao, Hebei, China. 17 device types, 15 products catalogued, 16 clearances.
Aidite (Qinhuangdao) Technology Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Bur, Dental, Scanner, Color and 15 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
17device types registered with the FDA
15products catalogued under its own name
16510(k) clearances
Registration
| Registered name | AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009482106 |
| FEI number | 3009482106 |
| DUNS | 529607549 |
| Establishment type | Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 爱迪特（秦皇岛）科技股份有限公司 |
|---|---|
| Unified social credit code | 91130300799573001U |
| Source | NMPA UDI database |
Location
| City | Qinhuangdao |
|---|---|
| Province | Hebei |
| Address | No.56 Tianchi Road & No.9 Dushan Road, Economic and Technological Development Zone |
| Postal code | 066004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | 3D Printing Material Surgical Guide, Model: APMR02 | 2022 | 70 |
| Additively Manufactured, Preformed, Resin Denture Tooth | Class 2 | Additive Manufacturing (Light Curing) Crown Bridge Resin | 2025 | 10 |
| Aligner, Sequential | Class 2 | Additively Manufactured Aligner Resin | 2025 | 14 |
| Alloy, Other Noble Metal | Class 2 | Aidite Firing Paste | 2019 | 12 |
| Bur, Dental | Class 1 | Aidite Dental Bur | 2019 | 46 |
| Crown And Bridge, Long-Term Temporary, Resin | Class 2 | Additive Manufacturing (Light Curing) Crown Bridge Resin | 2025 | 1 |
| Crown And Bridge, Temporary, Resin | Class 2 | Additive Manufacturing (Light Curing) Crown Bridge Resin, 3D Printing Material Temp, PMMA Blocks for Dental Use, FREEPRINT crown, 3D Printing Material Crown Bridge | 2023 | 13 |
| Loupe, Binocular, Low Power | Class 1 | binocular loupes | 2024 | 13 |
| Material, Impression Tray, Resin | Class 1 | 3D Printing Material Tryin, 3D Printing Try-in Material, APMR01 | 2017 | 41 |
| Material, Tooth Shade, Resin | Class 2 | Additive Manufacturing (Light Curing) Crown Bridge Resin, Light-curing Coloring Materials (ALCM), Dental Ceramic Blocks, FREEPRINT crown, 3D Printing Material Crown Bridge | 2023 | 10 |
| Mouthguard, Prescription | Class U | 3D Printing Material Splint, Additively Manufactured Aligner Resin | 2024 | 6 |
| Positioner, Tooth, Preformed | Class 1 | 3D Printing Material Splint | 2024 | 19 |
| Powder, Porcelain | Class 2 | Dental Zirconia Ceramic, UTM, Multilayer-3Dpro, UTC, Multilayer-3D, SHT-PRE-T and 5 more | 2020 | 33 |
| Resin, Denture, Relining, Repairing, Rebasing | Class 2 | Denture Base Resin, 3D Printing Material Denture Base, Freeprint denture, Additively Manufactured Denture Resin | 2023 | 14 |
| Scanner, Color | Class 2 | lntraoral Scanner; Model: Rapid 3, Rapid 5, Infinity 5, Intraoral Scanner | 2025 | 1 |
| Tray, Impression, Preformed | Class 1 | 3D Printing Material Gingiva Model, 3D Printing Material Model | 2019 | 73 |
| Wax, Dental, Intraoral | Class 1 | Dental Casting, 3D Printing Cast Material | 2017 | 55 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Aidite | EIH | 4,310 |
| Aidite Pmma | EBG | 642 |
| Cameo | EIH | 535 |
| Aidite Dental Bur | EJL | 294 |
| Aidite | EBF | 166 |
| Dental Casting | EGD | 103 |
| Aidite | EBG | 35 |
| Aidite | EBI | 28 |
| Aidite | EHY | 19 |
| Aidite 3D Printing Model Resin | EGD | 17 |
| Aidite 3D Printing Model Resin | EHY | 5 |
| Aidite | EJL | 5 |
| Aidite | EGD | 4 |
| Aidite Firing Paste | EJS | 1 |
| Aidite | EIG | 1 |
Clearances
16 clearances name Aidite (Qinhuangdao) Technology Co., Ltd. as applicant. 4 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253036 | 2026-04-06 | EBF | Traditional | This company |
| K251415 | 2025-08-27 | NXC | Traditional | This company |
| K250534 | 2025-05-20 | EIH | Traditional | This company |
| K250497 | 2025-04-30 | EBF | Traditional | This company |
| K250811 | 2025-04-11 | EIH | Special | This company |
| K250025 | 2025-03-14 | EIH | Traditional | This company |
| K242884 | 2024-11-22 | EBI | Traditional | This company |
| K241715 | 2024-07-12 | EIH | Special | This company |
| K230115 | 2023-03-17 | EBI | Traditional | This company |
| K223742 | 2023-03-08 | EBF | Traditional | This company |
| K223477 | 2023-02-16 | EBG | Traditional | This company |
| K222626 | 2022-12-06 | EIH | Traditional | This company |
| K213570 | 2022-01-07 | EIH | Traditional | This company |
| K190217 | 2020-12-17 | EBG | Traditional | This company |
| K192723 | 2020-08-18 | EIH | Traditional | This company |
| K192231 | 2020-07-08 | EIH | Traditional | This company |
| K232448 | 2023-10-12 | MQC | Traditional | Detax Gmbh |
| K222877 | 2022-09-23 | EBF | Traditional | Detax Gmbh |
| K200461 | 2020-11-16 | EBI | Traditional | Detax Gmbh |
| K200273 | 2020-10-27 | EBG | Traditional | Detax Gmbh |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Main products | Zirconia materials, Dental milling machines, 3D printers, CAD/CAM solutions |
| Certifications | CE, FDA |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Contec Medical Systems Co., Ltd. | 22 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | 11 |
| Qinhuangdao Taizhi Medical Technology Co., Ltd. | 5 |
| Qinhuangdao Huisianpu Medical Systems Inc. | 4 |
| Qinhuangdao Kapunuomaite Medical Equipment S&T Co., Ltd. | 3 |
| Qinhuangdao Silide Ceramic Technology Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.