FDA Registration
Active
🇨🇳 China
GUANGZHOU HEYGEARS IMC.INC
Reg #: 3021381014
·
FEI: 3021381014
·
Expires 2026
Products
10
Proprietary Names
39
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- GUANGZHOU HEYGEARS IMC.INC
- Registration Number
- 3021381014
- FEI Number
- 3021381014
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 201-1, No.25, Yayingshi Road, Huangpu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K253324
Owner / Operator
- Firm Name
- GUANGZHOU HEYGEARS IMC.INC
- Operator Number
- 10061379
- Address
- BLOCK B2,501,601,ENTERPRISE ACCELERATOR,KAIFA DISTRICT
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510700
- Country
- CN
- Correspondent
- Peiyan Gui
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2019-10-13 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2025-12-05 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2019-10-13 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2021-08-02 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2026-03-23 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2026-03-23 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2022-01-16 |
| Material, External Aesthetic Restoration, No Adhesive | NOK | Class 1 | General, Plastic Surgery | No | 2019-10-13 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2020-05-13 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2021-06-06 |
Proprietary Names
UltraPrint-Dental IBT UV
UltraPrint-Dental Model WW UV
UltraPrint-Dental Model TF UV
UltraPrint-Dental Tray UV
UltraPrint-Dental Model HP UV
UltraPrint-Dental Study Model UV
UltraPrint-Dental Model E UV
UltraPrint-Dental Model ES UV
UltraPrint-Dental Model HS UV
UltraPrint-Dental Model WW
UltraPrint-Dental Model M
UltraPrint-Dental Model GP
UltraPrint-Dental Model M UV
UltraPrint Tray UV
UltraPrint Denture UV
UltraPrint-Dental Denture UV
UltraPrint-Dental Surgical Guide UV
UltraPrint Surgical Guide UV
UltraPrint-Dental Cast UV
UltraPrint Cast UV
UltraPrint Hard Splint UV
UltraPrint Temp C&B UV
UltraPrint-Dental Temp C&B UV
UltraPrint-Dental Gingiva UV
UltraPrint Gingiva UV
UltraPrint On-X Teeth Try-in UV
UltraPrint Hard Splint Try-in UV
UltraPrint Flexible Try-in UV
UltraPrint-Dental Denture Try-in UV
UltraPrint Bleach Veil UV
UltraPrint -Dental Tough Teeth For Try-in UV
UltraPrint-Dental Try-in UV
UltraPrint Try-in UV
UltraPrint-Dental Flexible Try-in UV
UltraPrint Tough Teeth For Try-in UV
UltraPrint-Dental On-X Teeth Try-in UV
UltraPrint-Dental Hard Splint Try-in UV
UltraPrint-Dental Denture Teeth UV
UltraPrint Denture Teeth UV
Establishment Types
Manufacture Medical Device