Shanghai Smartee Denti-Technology Co., Ltd.
Registered establishment in Shanghai, China. 5 device types.
Shanghai Smartee Denti-Technology Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Aligner, Sequential, Indirect Bonding Tray and 3 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | SHANGHAI SMARTEE DENTI-TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015342395 |
| FEI number | 3015342395 |
| Establishment type | Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 2nd Floor, No.27& Room 201, 203, 204, 205, No.32 and No.34, Lane 565, Shengxia Road |
| Postal code | 201210 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Aligner, Sequential | Class 2 | Custom-made Invisible Aligners, Byte Aligner System, REF03 ClearCorrect System Aligners(Multi-layer) | 2019 | 14 |
| Band, Material, Orthodontic | Class 1 | Dental Sheet | 2024 | 16 |
| Indirect Bonding Tray | Class 1 | REF06 ClearCorrect System Engager Template | 2025 | 6 |
| Positioner, Tooth, Preformed | Class 1 | POSITIONER, TOOTH, PREFORMED, Clear Retainer (YCL-A-R, YCL-C-R), REF04 ClearCorrect System Retainer | 2025 | 19 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro;, Owandy ios; Owandy ios Wireless; ST 200E | 2024 | 36 |
Clearances
No clearance names Shanghai Smartee Denti-Technology Co., Ltd. as applicant. 5 are held by other companies 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 |
|---|---|---|---|---|
| K230199 | 2023-10-18 | NXC | Traditional | Dentsply Sirona Inc |
| K223454 | 2023-04-17 | NXC | Traditional | Zhejiang Yinchili Medical Technology Co., Ltd. |
| K203624 | 2022-06-16 | NXC | Traditional | Zhejiang Yinchili Medical Technology Co., Ltd. |
| K210320 | 2021-08-06 | NXC | Traditional | ClearCorrect, LLC |
| K180346 | 2019-02-19 | NXC | Traditional | Straight Smile, LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | Clear aligners, Dental thermoplastic sheets, Orthodontic solutions |
| Export markets | Germany, Japan, France, Spain, multiple international markets |
Nearby Manufacturers
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.