FDA Registration
Active
🇨🇳 China
Elastomeric Impression Material
Reg #: 3008320092
·
FEI: 3008320092
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shandong Huge Dental Material Corporation
- Registration Number
- 3008320092
- FEI Number
- 3008320092
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 68 Shanhai Road, Donggang District
- City
- Rizhao Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K133071
Owner / Operator
- Firm Name
- Shandong Huge Dental Material Corporation
- Operator Number
- 10031883
- Address
- No. 68 Shanhai Road, Donggang District
- City
- Rizhao
- State
- Shandong
- Postal Code
- 276800
- Country
- CN
- Correspondent
- Steven Song
US Agent
- Business Name
- HUGE DENTAL USA LLC
- Contact Name
- Xin Song
- Address
- 4010 Valley Blvd STE 104
- City
- Walnut
- State
- CA
- ZIP
- 91789
- Country
- US
- [email protected]
- Phone
- 626 2835808
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2014-05-30 |
Proprietary Names
Elastomeric Impression Material
Establishment Types
Manufacture Medical Device