# Smylio, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 4 (2018–2026): 4 510(k) clearances
- Product codes: NXC (4)
- 510(k) review time since 2016: median 156 days, against 122 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- 3D Diagnostix, Inc.: 1 (https://510kreport.com/company/3d-diagnostix)
- Ormco Corp.: 1 (https://510kreport.com/company/ormco)

## Firms that cite its devices most
- Laxmi Dental Export Pvt., Ltd.: 1 (https://510kreport.com/company/laxmi-dental-export-pvt)
- Ulab Systems, Inc.: 1 (https://510kreport.com/company/ulab-systems)
- Laxmi Dental Exports Pvt, Ltd.: 1 (https://510kreport.com/company/laxmi-dental-exports-pvt)
- Straight T, Inc.: 1 (https://510kreport.com/company/straight-t)
- Kline Europe GmbH: 1 (https://510kreport.com/company/kline-europe)
- Royal Dental Lab: 1 (https://510kreport.com/company/royal-dental-lab)
- Orthodent Laboratory, Inc.: 1 (https://510kreport.com/company/orthodent-laboratory)

## Its most-cited devices
- K173784: Smylic Invisible Clear Aligners (2018), cited by 5
- K212660: Smylio Invisible Clear Aligners (2021), cited by 3

## Recent decisions
- K260788: Smylio Aligners (May 8, 2026)
- K221537: Nightwear Aligners (Apr 5, 2023)
- K212660: Smylio Invisible Clear Aligners (Sep 22, 2021)
- K173784: Smylic Invisible Clear Aligners (Aug 23, 2018)

Source page: https://510kreport.com/company/smylio