FDA Registration
Active
🇯🇵 Japan
TOMY, INC.
Reg #: 8010342
·
FEI: 3002853098
·
Expires 2026
Products
12
Proprietary Names
0
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- TOMY, INC.
- Registration Number
- 8010342
- FEI Number
- 3002853098
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100-1 Bessho, Jobanfujiwaramachi
- City
- Iwaki City Fukushima
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K160615
Owner / Operator
- Firm Name
- TOMY, INC.
- Operator Number
- 8010342
- Address
- Tenko Blg. 3-16-7, Midoricho
- City
- Fuchu City
- State
- Tokyo
- Postal Code
- 183-0006
- Country
- JP
- Correspondent
- Kenji - Nagase
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 |
|---|---|---|---|---|---|
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 1978-03-01 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2016-09-09 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2018-12-25 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 1978-03-01 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2013-01-28 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2013-01-28 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 1978-03-01 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2013-01-28 |
| Clasp, Preformed | EHP | Class 1 | Dental | No | 2013-01-28 |
| Facebow | KCR | Class 1 | Dental | No | 1978-03-01 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 1981-04-08 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 1978-03-01 |
Establishment Types
Manufacture Medical Device