Data / Medical devices / United States / Sonrisa/Easy Denture/NSI
Sonrisa/Easy Denture/NSI: FDA-registered device maker in Wilmington, NC, United States, 1 510(k) clearance
Sonrisa/Easy Denture/NSI is registered with the FDA (registration 3015527834) in Wilmington, NC, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015527834
- Address
- 2105 Capital Dr Ste 300, Wilmington, NC, United States, 28405
- Owner or operator
- Sonrisa (10061748)
- Roles
- Specification developer
- First device listed
- November 15, 2019
- Registered through
- 2026
- Brand names listed
- Easy Denture, No Stress Impress, No Stress Impress PRO, Quick Reline
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Specification developer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Specification developer | accessdata.fda.gov |
| Reliner, Denture, Over The Counter | EBP | 2 | Specification developer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 19, 2023 | K213175 | No Stress Impress | ELW | Substantially Equivalent | No Stress Impress, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Wax, Dental, Intraoral
- All makers of Reliner, Denture, Over The Counter
- All makers of Denture Preformed (Partially Prefabricated Denture)
- All makers of Tray, Impression, Preformed
Updated January 19, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.