Manufacturer registered with FDA

Hangzhou ChohoTech Co., Ltd

Hangzhou, China. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10086116Manufacturer1 clearance in five years
Device types listed
4
Brands and models
8
510(k) clearances
12026–2026
Markets registered in
24 registrations outside the US
Establishments
1China
2026: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Hangzhou ChohoTech Co., Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 4 device types listedEuropean Union: 4 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerHangzhou ChohoTech Co., Ltd1 clearances2026–2026Below
European UnionEUDAMEDManufacturerHangzhou ChohoTech Co., Ltd4—Pure 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 Hangzhou ChohoTech Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersMaker
Intra oral camera (Ultra-S, Ultra-M, Ultra-L, Ultra-BP, Ultra-AP, Pro-S, Pro-M, Pro-L, Pro-BP, Pro-AP)LingOral Dental Design SystemRetractor (iScan-AP);
2023
Dental Retractor AccessoriesEIF · Class 1Dental hand instrumentsMaker
Intra oral camera (Ultra-S, Ultra-M, Ultra-L, Ultra-BP, Ultra-AP, Pro-S, Pro-M, Pro-L, Pro-BP, Pro-AP)Retractor (iScan-AP);
2022
All Types RetractorEIG · Class 1Dental hand instrumentsMaker
Intra oral camera (Ultra-S, Ultra-M, Ultra-L, Ultra-BP, Ultra-AP, Pro-S, Pro-M, Pro-L, Pro-BP, Pro-AP)Retractor (iScan-AP);
2022
Orthodontic SoftwarePNN · Class 2Dental design & orthodontic softwareMaker
LingOral Dental Design System
2026

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 Hangzhou ChohoTech Co., Ltd as the applicant.

Decided510(k)DeviceDevice type
8 May 2026K260419LingOral Dental Design SystemPNN Orthodontic Software

Registered establishments

EstablishmentLocationWhat it does
HANGZHOU CHOHOTECH CO., LTDFDA reg. 3025359603Hangzhou Zhejiang, ChinaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10086116). 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.