Dental Device Guide
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Manufacturer registered with FDA

Ningbo Xinwell Medical Technology Co., Ltd.

Cixi, China. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10075092Contract manufacturer
Device types listed
1
Brands and models
3
510(k) clearances
0as applicant
Markets registered in
1163 registrations outside the US
Establishments
1China

Registered in 11 markets

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

All markets
United States: 1 device types listedUnited Kingdom: 15 registrationsBrazil: 12 registrationsEuropean Union: 11 registrationsCanada: 8 registrationsSouth Korea: 7 registrationsIsrael: 3 registrationsAustralia: 2 registrationsColombia: 2 registrationsHong Kong: 2 registrationsPeru: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerNingbo Xinwell Medical Technology Co., Ltd.1 device types—Below
United KingdomMHRAManufacturerNingbo Xinwell Medical Technology Co., Ltd.15—Pure Global AI
BrazilANVISAManufacturerNINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD122023–2026Pure Global AI
European UnionEUDAMEDManufacturerNingbo Xinwell Medical Technology Co., Ltd11—Pure Global AI
CanadaHealth CanadaRegistration holderNINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.82025–2026Pure Global AI
South KoreaMFDSManufacturerNingbo Xinwell Medical Technology Co., Ltd.72023–2026Pure Global AI
IsraelAMARManufacturerNingbo Xinwell Medical Technology Co., Ltd.Ningbo Xinwell Medical Technology Co., Ltd3—Pure Global AI
AustraliaTGAManufacturerNingbo Xinwell Medical Technology Co Ltd22026–2026Pure Global AI
ColombiaINVIMAManufacturerNINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.2—Pure Global AI
Hong KongMDDManufacturerNingbo Xinwell Medical Technology Co., Ltd.22026–2026Pure Global AI
PeruDIGEMIDManufacturerNINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.12022–2022Pure 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 Ningbo Xinwell Medical Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Abrasive PointEHL · Class 1Polishing & prophylaxisMaker
All Ceramic PolishersFlexiPointsMASS SPECTROMETRY MONITORING LINE CONONECTORS
2008

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3017178358Cixi Zhejiang, ChinaContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10075092). 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.