Manufacturer registered with FDA
Guangzhou Heygears IMC., Inc.
Guangzhou, China. Lists 7 dental device types with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 11
- 510(k) clearances
- 32022–2026
- Markets registered in
- 723 registrations outside the US
- Establishments
- 2China
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Guangzhou Heygears IMC., Inc. 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 | Guangzhou Heygears IMC., Inc. | 3 clearances | 2022–2026 | Below |
| European Union | EUDAMED | Manufacturer | GUANGZHOU HEYGEARS IMC.INC | 10 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Guangzhou Heygears Imc Inc | 4 | 2022–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GUANGZHOU HEYGEARS IMC.INC | 4 | 2022–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GUANGZHOU HEYGEARS IMC. INC | 2 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Guangzhou Heygears IMC.INC | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | GUANGZHOU HEYGEARS IMC.INC | 1 | 2022–2022 | 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 Guangzhou Heygears IMC., Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | UltraPrint Denture UVUltraPrint Flexible Denture UV | 2025 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | UltraPrint Temp C&B UV | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | UltraPrint Tray UV | 2019 |
| Shellac Base PlateEEA · Class 1 | — | Maker | UltraPrint Bleach Veil UVUltraPrint Flexible Try-in UVUltraPrint On-X Teeth Try-in UVUltraPrint Try-in UV | 2020 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | UltraPrint Hard Splint UV | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | UltraPrint Surgical Guide UV | 2019 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | UltraPrint Denture Teeth UV | 2021 |
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 Guangzhou Heygears IMC., Inc. as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GUANGZHOU HEYGEARS IMC.INCFDA reg. 3015674635 | Guangzhou Guangdong, China | Specification developer |
| JIANGXI HEYGEARS INNOVATIVE MATERIAL CO., LTDFDA reg. 3021381014 | Jiujiang Jiangxi, China | Contract manufacturer |
Other names on FDA records
Jiangxi Heygears Innovative Material Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061379). 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.