FDA Registration
Active
🇺🇸 United States
Sonrisa/Easy Denture/NSI
Reg #: 3015527834
·
FEI: 3015527834
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Sonrisa/Easy Denture/NSI
- Registration Number
- 3015527834
- FEI Number
- 3015527834
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2105 Capital Dr Ste 300
- City
- Wilmington
- State
- NC
- ZIP
- 28405
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213175
Owner / Operator
- Firm Name
- Sonrisa
- Operator Number
- 10061748
- Address
- 304 Fair Lakes Dr
- City
- Wilmington
- State
- NC
- Postal Code
- 28405
- Country
- US
- Correspondent
- Misael Otero
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reliner, Denture, Over The Counter | EBP | Class 2 | Dental | No | 2024-06-14 |
| Denture Preformed (Partially Prefabricated Denture) | EKO | Class 2 | Dental | No | 2019-11-15 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2020-12-30 |
| Material, Impression | ELW | Class 2 | Dental | No | 2023-12-01 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2020-12-30 |
Proprietary Names
Quick Reline
Easy Denture
No Stress Impress
No Stress Impress PRO
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility