FDA Registration
Active
🇰🇷 South Korea
HDI INC.
Reg #: 3025307990
·
FEI: 3025307990
·
Expires 2026
Products
18
Proprietary Names
29
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- HDI INC.
- Registration Number
- 3025307990
- FEI Number
- 3025307990
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- A-504, 14, Sagimakgol-ro, 45beon-gil, Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K222741
Owner / Operator
- Firm Name
- HDI Inc.
- Operator Number
- 10086700
- Address
- A-1504, 14, Sagimakgol-ro, 45beon-gil, Jungwon-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13209
- Country
- KR
- Correspondent
- Taekyou Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dam, Rubber | EIE | Class 1 | Dental | No | 2023-06-23 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2023-06-23 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2023-06-23 |
| Tray, Fluoride, Disposable | KMT | Class 1 | Dental | No | 2023-06-23 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2023-06-23 |
| Material, Impression | ELW | Class 2 | Dental | No | 2022-12-04 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2023-06-23 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2023-06-23 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2023-06-23 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2022-12-04 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2022-12-04 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2023-06-23 |
| Floss, Dental | JES | Class 1 | Dental | No | 2023-06-13 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2023-06-23 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2023-06-23 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2023-06-23 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2023-06-23 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2023-06-23 |
Proprietary Names
Denu Fil Flow
Denu Dam
Denu TemCement Cleaner
Denu Ultra Cleaner
Denu Suction Cleaner
Denu Tray Cleaner
Denu Fluoride Gel Tray
Denu Plastic Probe
DENU Heavy Body(Regular, Fast)
DENU Light Body(Regular, Fast)
DENU Putty Set(Regular, Fast)
Denu Suction Plus Mouth Prop
Denu Pumice Paste
Denu Suction Plus Retractor
DENU Flow Resin
DENU Composite Resin
Denu Jig Paste
Denu Block-Out Resin
Denu Jig Handy
Denu TemTooth
Denu GingiCord
Denu EDTA Cream
Denu Dual Tray UL; Denu Dual Tray LL; Denu Dual Tray UM; Denu Dual Tray LM; Denu Dual Tray US; Denu Dual Tray LS
Denu Dual Tray PA; Denu Dual Tray PB; Denu Dual Tray P1; Denu Dual Tray P2
Denu Stick Free
Denu Shim Stock
Denu Intraoral Camera Cover
Denu Bite Block Cover
Denu Digital Sensor Cover
Establishment Types
Manufacture Medical Device