Manufacturer registered with FDA
Sonrisa
Wilmington, NC, United States. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Sonrisa currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | Quick Reline | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | No Stress Impress | 2020 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | No Stress Impress | 2020 |
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Maker | Easy Denture | 2019 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | No Stress Impress PRO | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sonrisa lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: No Stress Impress, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Jan 2023 | K213175 | No Stress Impress | No Stress Impress, LLC | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Sonrisa/Easy Denture/NSIFDA reg. 3015527834 | Wilmington, NC, United States | Specification developer |
Other names on FDA records
Sonrisa/Easy Denture/NSI
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061748). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.