FDA Registration
Active
🇯🇵 Japan
ImageWorks Panoura
Reg #: 3013360312
·
FEI: 3013360312
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MD INSTRUMENTS MFG. CO.,LTD.
- Registration Number
- 3013360312
- FEI Number
- 3013360312
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3262-3 Kamata, Yoshiwara, Amimachi
- City
- Inashiki-Gun Ibaraki
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K122806
Owner / Operator
- Firm Name
- THE YOSHIDA DENTAL MFG. CO., LTD.
- Operator Number
- 8030214
- Address
- 1-3-6, KOTOBASHI, SUMIDA-KU, --
- City
- TOKYO
- State
- JP-NOTA
- Postal Code
- 130 8516
- Country
- JP
US Agent
- Business Name
- Kamm & Associates
- Contact Name
- Daniel Kamm
- Address
- 8870 Ravello Ct
- City
- Naples
- State
- FL
- ZIP
- 34114
- Country
- US
- [email protected]
- Phone
- 239 4171727
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2013-03-28 |
Proprietary Names
ImageWorks Panoura
Panoura 18S
X-era Smart
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)