Data / Medical devices / United States / Smylio
Smylio: FDA-registered device maker in Fremont, CA, United States, 3 510(k) clearances
Smylio is registered with the FDA (registration 3015143007) in Fremont, CA, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 5, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015143007
- Address
- 48890 Milmont Drive Ste 101D, Fremont, CA, United States, 94538
- Owner or operator
- Smylio (10058597)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 16, 2020
- Registered through
- 2026
- Brand names listed
- AirFlex Aligners, FXBright Aligner, FXBright Retainers, FXClear Aligner, FXClear Retainers, FXTetra Bright Retainers, NiTime Aligners, OrthoFX Tray and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 5, 2023 | K221537 | Nightwear Aligners | NXC | Substantially Equivalent | Smylio, Inc. | accessdata.fda.gov |
| September 22, 2021 | K212660 | Smylio Invisible Clear Aligners | NXC | Substantially Equivalent | Smylio, Inc. | accessdata.fda.gov |
| August 5, 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | ELW | Substantially Equivalent | Discus Dental, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wax, Dental, Intraoral
- All makers of Aligner, Sequential
- All makers of Tray, Impression, Preformed
- All makers of Maintainer, Space Preformed, Orthodontic
- All makers of Material, Impression
Updated April 5, 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.