Manufacturer registered with FDA
Huvitz Company Ltd
Anyang-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 16234 registrations outside the US
- Establishments
- 1South Korea
Registered in 16 markets
Where regulators' registries name Huvitz Company Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Huvitz Company Ltd | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Huvitz Co., Ltd.HUVITZ CO., LTD. | 52 | 2006–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Huvitz Co., Ltd. | 29 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | HUVITZ CO., LTD. | 27 | 2006–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HUVITZ CO LTDHUVITZ CO., LTD. | 21 | 2015–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Huvitz Co., Ltd. | 19 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Huvitz Co. Ltd.HUVITZ CO LTD · HUVITZ CO. LTD. · +2 | 17 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HUVITZ CO., LTD.HUVITZ CO., LTD · HUVITZ Co., Ltd. | 17 | 2022–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | HUVITZ CO., LTD.Huvitz CO., LTD | 16 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Huvitz Co., Ltd. | 13 | 2022–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Huvitz Company Ltd | 9 | 2017–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Huvitz Co., LtdHUVITZ Co., Ltd. · Huvitz Co. Ltd. | 5 | — | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Huvitz Co. Limited | 4 | 2024–2026 | Pure Global AI |
| China | NMPA | Registration holder | 湖碧驰有限公司Huvitz Co., Ltd. | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HUVITZ CO., LTD | 1 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Huvitz Co., Ltd. | 1 | 2025–2025 | 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 Huvitz Company Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | IntraOral Scanner LS-100IntraOral Scanner LSO-100Lilivis CAD L-CADLS-100-TIP-3RLS-100-TIP-3SLSO-100-TIP-NORMALLSO-100-TIP-SMALL | 2024 |
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
| Establishment | Location | What it does |
|---|---|---|
| HUVITZ CO., LTD.FDA reg. 9616199 | Anyang-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9039310). 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.