Data / Medical devices / China / Shanghai Smartee Denti-Technology Co., Ltd.

Shanghai Smartee Denti-Technology Co., Ltd.: FDA-registered device maker in Shanghai, China, 5 510(k) clearances

Name: Shanghai Smartee Denti-Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Smartee Denti-Technology Co., Ltd. is registered with the FDA (registration 3015342395) in Shanghai, China. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 18, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Shanghai Smartee Denti-Technology Co., Ltd.

FDA registration number: 3015342395
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, China, 201210
Owner or operator: Shanghai Smartee Denti-Technology Co., Ltd. (10060314)
Roles: Exporter to the US
First device listed: April 24, 2019
Registered through: 2026
Brand names listed: AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro;, Byte Aligner System, Custom-made Invisible Aligners, Dental Sheet, Owandy ios; Owandy ios Wireless; ST 200E, POSITIONER, TOOTH, PREFORMED, Clear Retainer (YCL-A-R, YCL-C-R), REF04 ClearCorrect System Retainer, REF03 ClearCorrect System Aligners(Multi-layer), REF06 ClearCorrect System Engager Template

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Sequential	NXC	2	Exporter to the US	accessdata.fda.gov
Band, Material, Orthodontic	DYO	1	Exporter to the US	accessdata.fda.gov
Indirect Bonding Tray	QJJ	1	Exporter to the US	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Exporter to the US	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 18, 2023	K230199	Byte Aligner System	NXC	Substantially Equivalent	Dentsply Sirona, Inc.	accessdata.fda.gov
April 17, 2023	K223454	Custom-made Invisible Aligners	NXC	Substantially Equivalent	Zhejiang Yinchili Medical Technology Co., Ltd.	accessdata.fda.gov
June 16, 2022	K203624	Custom-made Invisible Aligners	NXC	Substantially Equivalent	Zhejiang Yinchili Medical Technology Co., Ltd.	accessdata.fda.gov
August 6, 2021	K210320	ClearCorrect System	NXC	Substantially Equivalent	Clearcorrect, LLC	accessdata.fda.gov
February 19, 2019	K180346	Byte Aligner System	NXC	Substantially Equivalent	Straight Smile, LLC	accessdata.fda.gov

Compare with other makers

Updated October 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.