FDA Registration
Active
🇯🇵 Japan
PTL-CL-FV-T
Reg #: 9611253
·
FEI: 3002807687
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NAKANISHI INC.
- Registration Number
- 9611253
- FEI Number
- 3002807687
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 700 SHIMOHINATA
- City
- Kanuma Tochigi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K203791
Owner / Operator
- Firm Name
- NAKANISHI INC.
- Operator Number
- 8030216
- Address
- 1800 Global Pkwy
- City
- Hoffman Est
- State
- IL
- Postal Code
- 60192
- Country
- US
- Correspondent
- Satoru Ikeda
US Agent
- Business Name
- NSK AMERICA CORPORATION
- Contact Name
- SEAN KAUFMAN
- Address
- 1800 Global Pkwy
- City
- Hoffman Est
- State
- IL
- ZIP
- 60192
- Country
- US
- [email protected]
- Phone
- 888 6751675
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2022-10-19 |
Proprietary Names
PTL-CL-FV-T
QD-J B2/B3
FM-CL-M4
S-Max pico BLED
M800KL
M800WL
PAP2-SU M4
PAP2-MU M4
M900
PTL-CL-LED III
PTL-CL-LED
M900W
S-Max pico
M800L
S-Max pico WLED
M800
S-Max pico KL
M900K
FM-CL-M4-T
QD-J M4
S-Max pico SL
M900L
M900KL
Pana-Max2 M4
M900WL
KCL-LED
Establishment Types
Manufacture Medical Device