Guangzhou Heygears Imc.inc
Manufacturer and brand owner in Guangzhou, Guangdong, China. 8 device types, 9 products catalogued, 4 clearances.
Guangzhou Heygears Imc.inc is a specification developer holding a current FDA establishment registration. The registration covers Plate, Base, Shellac, Mouthguard, Prescription and 6 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | GUANGZHOU HEYGEARS IMC.INC |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015674635 |
| FEI number | 3015674635 |
| DUNS | 418561545 |
| Establishment type | Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 广州黑格智造信息科技有限公司 |
|---|---|
| Unified social credit code | 91440101MA59EDH20Q |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Block B2, 501, 601, Enterprise Accelerator, Kaifa District |
| Postal code | 510700 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | UltraPrint Surgical Guide UV | 2019 | 70 |
| Additively Manufactured, Preformed, Resin Denture Tooth | Class 2 | UltraPrint Denture Teeth UV | 2021 | 10 |
| Crown And Bridge, Temporary, Resin | Class 2 | UltraPrint Temp C&B UV | 2022 | 13 |
| Material, Impression Tray, Resin | Class 1 | UltraPrint Tray UV | 2019 | 41 |
| Mouthguard, Prescription | Class U | UltraPrint Hard Splint UV | 2026 | 6 |
| Plate, Base, Shellac | Class 1 | UltraPrint On-X Teeth Try-in UV, UltraPrint Bleach Veil UV, UltraPrint Try-in UV, UltraPrint Flexible Try-in UV | 2020 | 5 |
| Positioner, Tooth, Preformed | Class 1 | UltraPrint Hard Splint UV | 2026 | 19 |
| Resin, Denture, Relining, Repairing, Rebasing | Class 2 | UltraPrint Denture UV, UltraPrint Flexible Denture UV | 2025 | 14 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| UltraPrint-Dental Denture Teeth UV | PZY | 32 |
| UltraPrint-Dental Temp C&B UV | EBG | 32 |
| UltraPrint-Dental Denture UV | EBI | 12 |
| UltraPrint Denture Teeth UV | PZY | 10 |
| UltraPrint Denture UV | EBI | 9 |
| UltraPrint Temp C&B UV | EBG | 5 |
| UltraPrint-Dental Surgical Guide UV | NDP | 3 |
| UltraPrint Surgical Guide UV | NDP | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261626 | 2026-08-13 | EBI | Traditional | This company |
| K253798 | 2026-03-02 | MQC | Traditional | This company |
| K253324 | 2025-11-20 | EBI | Traditional | This company |
| K213643 | 2022-01-14 | EBG | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2015 |
|---|---|
| Main products | Resin 3D printer, 3D printing material, Post-processing system |
| Certifications | National High-tech Enterprise, NMPA Class III |
| Export markets | Global (America, Europe, Asia) |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.