Registered with FDA
Shanghai Smartee Denti-Technology Co., Ltd.
Shanghai, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Shanghai Smartee Denti-Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Lister | Byte Aligner SystemCustom-made Invisible AlignersREF03 ClearCorrect System Aligners(Multi-layer) | 2019 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Lister | Dental Sheet | 2024 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Lister | POSITIONER, TOOTH, PREFORMED, Clear Retainer (YCL-A-R, YCL-C-R), REF04 ClearCorrect System Retainer | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | 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 |
| Indirect Bonding TrayQJJ · Class 1 | — | Lister | REF06 ClearCorrect System Engager Template | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Shanghai Smartee Denti-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: Zhejiang Yinchili Medical Technology Co.,Ltd (2), Dentsply Sirona, Inc. (1), Institut Straumann AG (1), Straight Smile, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Oct 2023 | K230199 | Byte Aligner System | Dentsply Sirona, Inc. | NXC Sequential Aligner |
| 17 Apr 2023 | K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co.,Ltd | NXC Sequential Aligner |
| 16 Jun 2022 | K203624 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co.,Ltd | NXC Sequential Aligner |
| 6 Aug 2021 | K210320 | ClearCorrect System | Institut Straumann AG | NXC Sequential Aligner |
| 19 Feb 2019 | K180346 | Byte Aligner System | Straight Smile, LLC | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHANGHAI SMARTEE DENTI-TECHNOLOGY CO., LTD.FDA reg. 3015342395 | Shanghai, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060314). 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.