FDA Registration
Active
🇯🇵 Japan
CERABIEN ZR TRIAL KIT SS NV1120
Reg #: 9614705
·
FEI: 3009523116
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT
- Registration Number
- 9614705
- FEI Number
- 3009523116
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 300 HIGASHIYAMA, MIYOSHI-CHO
- City
- MIYOSHI Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K170834
Owner / Operator
- Firm Name
- KURARAY NORITAKE DENTAL INC.
- Operator Number
- 10031961
- Address
- 1621 SAKAZU
- City
- KURASHIKI
- State
- Okayama
- Postal Code
- 710-0801
- Country
- JP
- Correspondent
- Satoshi Yamaguchi
US Agent
- Business Name
- KURARAY AMERICA INC.
- Contact Name
- MANABU SUZUKI
- Address
- 32 Old Slip, 7th Floor,
- City
- New York
- State
- NY
- ZIP
- 10005
- Country
- US
- [email protected]
- Phone
- 212 3563940
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2017-10-18 |
Proprietary Names
CERABIEN ZR TRIAL KIT SS NV1120
CERABIEN ZR TRIAL KIT SS A2
CERABIEN ZR VALUE SHADE FULL KIT
CERABIEN ZR SS BASIC FULL KIT
CERABIEN ZR
CERABIEN ZR SS ESTHETIC WHITE KIT
Establishment Types
Manufacture Medical Device