Manufacturer registered with FDA

Zhejiang Yinchili Medical Technology Co.,Ltd

Jiaxing City, China. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10060317Contract manufacturerManufacturer2 clearances in five years
Device types listed
3
Brands and models
4
510(k) clearances
22022–2023
Markets registered in
711 registrations outside the US
Establishments
1China
2022: 12023: 120102020

510(k) clearances per year, 2007–2026

Registered in 7 markets

Where regulators' registries name Zhejiang Yinchili Medical Technology Co.,Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 3 device types listedTaiwan: 3 registrationsAustralia: 2 registrationsCosta Rica: 2 registrationsUnited Kingdom: 2 registrationsColombia: 1 registrationsPeru: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerZhejiang Yinchili Medical Technology Co.,Ltd2 clearances2022–2023Below
TaiwanTFDAManufacturerZhejiang Yinchili Medical Technology Co., Ltd.ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO., LTD32016–2025Pure Global AI
AustraliaTGAManufacturerZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO LTD22024–2025Pure Global AI
Costa RicaMinisterio de SaludManufacturerZhejiang Yinchili Medical Technology Co., Ltd.2—Pure Global AI
United KingdomMHRAManufacturerZhejiang Yinchili Medical Technology Co., Ltd.2—Pure Global AI
ColombiaINVIMAManufacturerZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO. LTD.1—Pure Global AI
PeruDIGEMIDManufacturerZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO., LTD.12026–2026Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Zhejiang Yinchili Medical Technology Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Sequential AlignerNXC · Class 2Clear alignersMaker
ClearCorrect SystemCustom-made Invisible Aligners
2022
Preformed Tooth PositionerKMY · Class 1Retainers, expanders & headgearMaker
REF04 ClearCorrect System Retainer, Clear Retainer (YCL-A-R, YCL-C-R)
2025
Indirect Bonding TrayQJJ · Class 1—Maker
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

510(k) clearances

Clearances on which FDA names Zhejiang Yinchili Medical Technology Co.,Ltd as the applicant.

Decided510(k)DeviceDevice type
17 Apr 2023K223454Custom-made Invisible AlignersNXC Sequential Aligner
16 Jun 2022K203624Custom-made Invisible AlignersNXC Sequential Aligner

Registered establishments

EstablishmentLocationWhat it does
ZHEJIANG YINCHILI MEDICAL TECHNOLOGY CO.,LTDFDA reg. 3015341209Jiaxing City Zhejiang, ChinaContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10060317). 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.