FDA Registration
Active
🇨🇳 China
DENJOY DENTAL CO., LTD
Reg #: 3008590661
·
FEI: 3008590661
·
Expires 2026
Products
14
Proprietary Names
15
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- DENJOY DENTAL CO., LTD
- Registration Number
- 3008590661
- FEI Number
- 3008590661
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- F4, A4 Bld, Lugu Medical Device Park, No. 229 Guyuan Road,
- City
- Changsha city Hunan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242317
Owner / Operator
- Firm Name
- DENJOY DENTAL CO., LTD
- Operator Number
- 10034843
- Address
- F4, A4 Bld, Lugu Medical Device Park, No. 229 Guyuan Road
- City
- Changsha city
- State
- Hunan
- Postal Code
- 410205
- Country
- CN
- Correspondent
- Sheng Zhong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2022-01-04 |
| Dental Prophylaxis Kit | NYC | Class 1 | Dental | No | 2022-01-04 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2011-02-16 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2011-02-16 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2016-09-21 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2025-02-16 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2025-02-16 |
| Camera, Cine, Endoscopic, With Audio | FTS | Class 1 | General, Plastic Surgery | No | 2011-02-16 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2011-02-16 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2014-12-05 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2023-11-09 |
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2020-03-09 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-16 |
| Tester, Pulp | EAT | Class 2 | Dental | No | 2016-08-17 |
Proprietary Names
Dental Suction Unit
Root Canal Instruments Kit
RETRACTOR
LED WHITENING LIGHT
CORDLESS GUTTA PERCHA OBTURATION SYSTEM, HAND PLUGGER,CORDLESS GUTTA PERCHA OBTURATION PEN
GY-DP Gutta Percha Obturation System
Integrated Endo System (Meet Endo-II)
INTRAORAL CAMERA
ENDO MOTOR,ENDO TREATMENT INSTRUMENT, LOW-VOLTAGE ELECTRIC MOTOR
ENDO HAND FILE
HAND FILE, ROTARY FILE
Rotary File,K-File,H-File,K-Reamer
MEDICAL MICROSCOPE
Face Shield
PULP TESTER
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)