FDA Registration
Active
🇨🇳 China
Stainless steel dental root canal files(K-files, H-files, Reamers, Spreaders, Pluggers, C+ files, U-files)
Reg #: 3021284315
·
FEI: 3021284315
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- DONGGUAN INTEGRITY MEDICAL INSTRUMENT CO.,LTD.
- Registration Number
- 3021284315
- FEI Number
- 3021284315
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 602, Building 2, No.19 Tianxin Binhe Street, Huangjiang Town,
- City
- Dongguan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Dongguan Integrity Medical Instrument Co.,Ltd.
- Operator Number
- 10083415
- Address
- Room 602, Building 2, No.19 Tianxin Binhe Street, Huangjiang Town,
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523763
- Country
- CN
- Correspondent
- Jianguo Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2021-11-18 |
Proprietary Names
Stainless steel dental root canal files(K-files, H-files, Reamers, Spreaders, Pluggers, C+ files, U-files)
Endodontic instruments (Gate drills, Peeso reamers)
Paste carriers
Hand use files (PT-files hand use, PT-files blue hand use)
Endodontic Root Canal Files: NiTi dental root canal files (K-files, H-files, Reamers, Spreaders, Pluggers)
Engine endodontic files(Retreatment files,PT-files,PT-files blue,PT-files gold,PT-next, Only one gold, V-silver, V-blue
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device