Data / Medical devices / United States / Softsmile, Inc.
Softsmile, Inc.: FDA-registered device maker in Long Island City, NY, United States, 1 510(k) clearance
Softsmile, Inc. is registered with the FDA (registration 3024438491) in Long Island City, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024438491
- Address
- 1139 49th Ave. Apt 1012, Long Island City, NY, United States, 11101
- Owner or operator
- SoftSmile, Inc. (10086067)
- Roles
- Specification developer
- First device listed
- October 13, 2022
- Registered through
- 2026
- Brand names listed
- Vision
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthodontic Software | PNN | 2 | Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | 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 |
|---|---|---|---|---|---|---|
| December 21, 2021 | K212770 | Vision | PNN | Substantially Equivalent | Softsmile, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 21, 2021. 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.