Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015342395

FEI Number

3015342395

Entity Name

SHANGHAI SMARTEE DENTI-TECHNOLOGY CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

2nd Floor, No.27& Room 201, 203, 204, 205, No.32 and No.34, Lane 565, Shengxia Road, China (Shanghai) pilot free trade zone, Shanghai 201210, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shanghai Smartee Denti-Technology Co., Ltd. (Owner Number: 10060314)

Owner / Operator Contact Address

2nd Floor, No.27& Room 201, 203, 204, 205, No.32 and No.34, Lane 565, Shengxia Road, China (Shanghai) pilot free trade zone, Shanghai, CN-NOTA 201210, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203624

PMA Number

N/A

All Registered Proprietary Names

POSITIONER, TOOTH, PREFORMED, Clear Retainer (YCL-A-R, YCL-C-R), REF04 ClearCorrect System Retainer Custom-made Invisible Aligners Dental Sheet REF06 ClearCorrect System Engager Template Byte Aligner System REF03 ClearCorrect System Aligners(Multi-layer) 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 Custom-made Invisible Aligners

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2025-04-03
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2024-01-24
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2024-01-24
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2025-12-06
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-04-03
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2025-12-06
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2019-04-24
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2024-10-30
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2024-01-24

Official Correspondent

Junfeng Yao

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai Smartee Denti-Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015342395. Last updated year: 2026. Please use registration number 3015342395 when referencing this establishment in official correspondence.