FDA Registration
Active
🇯🇵 Japan
MANI, INC. (TAKANEZAWA FACILITY)
Reg #: 8030343
·
FEI: 1000550480
·
Expires 2026
Products
8
Proprietary Names
48
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- MANI, INC. (TAKANEZAWA FACILITY)
- Registration Number
- 8030343
- FEI Number
- 1000550480
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 743 NAKAAKUTSU, TAKANEZAWA
- City
- SHIOYA Tochigi
- Country
- JP
Owner / Operator
- Firm Name
- MANI, INC. (HEAD OFFICE)
- Operator Number
- 8030343
- Address
- 8-3 KIYOHARA INDUSTRIAL PARK, --
- City
- UTSUNOMIYA, TOCHIGI
- State
- JP-NOTA
- Postal Code
- 321-3231
- Country
- JP
- Correspondent
- Toshiharu Kamei
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2002-05-01 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2002-06-26 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1992-12-03 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2002-05-01 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2002-06-26 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 1982-08-06 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2002-10-29 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 1981-10-01 |
Proprietary Names
MANI PLUGGERS
FINGER PLUGGER
PLUGGER
MANI DIA-BURS
MI Stainless Burs
MANI STAINLESS BURS
MANI STAINLESS BURS HARD
MANI CARBIDE BURS
MANI SPREADERS
FINGER SPREADER
MANI FLARE SPREADERS
SPREADER
Peeso Reamers
Gates Drills
MANI GATES DRILLS
MANI PEESO REAMERS
Paste Fillers
MANI GLIDE FINDERS
MANI JIZAI
MANI H-FILES
MANI FLEXILE FILES
MANI PASTE CARRIERS
JIZAI GLIDER
MANI MEDIUM FLEXILE FILES
MANI MICRO FILES TYPE H
MANI FLARE FILES
MANI K-FILES
MANI MEDIUM FLARE FILES
MANI SEC O-FILES, H
MANI RT FILES
MANI FLARE FILES NiTi
MANI SEC O-FILES, K
MANI MICRO FILES TYPE K
MANI H-FILES NiTi
MANI NiTi FILES
MANI MICRO FILES TYPE F
MANI SUPER FILES
MANI MEDIUM H-FILES
MANI MEDIUM K-FILES
MANI D FINDERS
MANI MICRO FILES TYPE U
MANI SEC O-FILES
MANI NiTi FILES R
MANI U-FILES
MANI SHORT BARBED BROACHES
MANI MEDIUM REAMERS
MANI REAMERS
MANI ENGINE REAMERS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)