Data / Medical devices / China / Guangzhou Heygears Imc.inc
Guangzhou Heygears Imc.inc: FDA-registered device maker in Guangzhou Guangdong, China, 4 510(k) clearances
Guangzhou Heygears Imc.inc is registered with the FDA (registration 3015674635) in Guangzhou Guangdong, China. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015674635
- Address
- Block B2, 501, 601, Enterprise Accelerator, Kaifa District, Guangzhou Guangdong, China, 510700
- Owner or operator
- GUANGZHOU HEYGEARS IMC.INC (10061379)
- Roles
- Specification developer
- First device listed
- October 13, 2019
- Registered through
- 2026
- Brand names listed
- UltraPrint Bleach Veil UV, UltraPrint Denture Teeth UV, UltraPrint Denture UV, UltraPrint Flexible Denture UV, UltraPrint Flexible Try-in UV, UltraPrint Hard Splint UV, UltraPrint On-X Teeth Try-in UV, UltraPrint Surgical Guide UV and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Specification developer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Specification developer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Specification developer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 13, 2026 | K261626 | UltraPrint Flexible Denture UV | EBI | Substantially Equivalent | Guangzhou Heygears IMC., Inc. | accessdata.fda.gov |
| March 2, 2026 | K253798 | UltraPrint-Dental Hard Splint UV | MQC | Substantially Equivalent | Guangzhou Heygears IMC., Inc. | accessdata.fda.gov |
| November 20, 2025 | K253324 | UltraPrint-Dental Denture UV | EBI | Substantially Equivalent | Guangzhou Heygears IMC., Inc. | accessdata.fda.gov |
| January 14, 2022 | K213643 | UltraPrint-Dental Temp C&B UV | EBG | Substantially Equivalent | Guangzhou Heygears IMC., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Mouthguard, Prescription
- All makers of Positioner, Tooth, Preformed
- All makers of Plate, Base, Shellac
Updated August 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.