FDA Registration
Active
🇨🇳 China
DONGGUAN INTEGRITY MEDICAL INSTRUMENT CO.,LTD.
Reg #: 3021284315
·
FEI: 3021284315
·
Expires 2026
Products
5
Proprietary Names
12
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- DONGGUAN INTEGRITY MEDICAL INSTRUMENT CO.,LTD.
- Registration Number
- 3021284315
- FEI Number
- 3021284315
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2025-12-10 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2025-12-10 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2022-11-13 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2021-11-18 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2025-12-10 |
Proprietary Names
Absorbent Paper Points, Model:Taper 04/06 with LengthMark, for Protaper with LengthMark
Absorbent Paper Points, Model: Taper 02, Taper 04/0/06, for Protaper, Taper 02 with LengthMark
Gutta Percha Point, Model: for Protaper with LengthMark
Gutta Percha Point, Model: Taper02, 04/06, for Protaper,Taper 02 with LengthMark,Taper 04/0/06 with LengthMark
Barbed Broach (Nerve Broach) Length: 21mm/25mm Model: 0#,1#, 2#, 3#, 4#, 5#, 6#, 0-6#
Paste carriers
Stainless steel dental root canal files(K-files, H-files, Reamers, Spreaders, Pluggers, C+ files, U-files)
Endodontic Root Canal Files: NiTi dental root canal files (K-files, H-files, Reamers, Spreaders, Pluggers)
Hand use files (PT-files hand use, PT-files blue hand use)
Engine endodontic files(Retreatment files,PT-files,PT-files blue,PT-files gold,PT-next, Only one gold, V-silver, V-blue
Endodontic instruments (Gate drills, Peeso reamers)
Blue Diamond Bur; Carbide Bur; Stainless Bur
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)