# NuSmile, Ltd.

- Location (FDA's records): Houston, TX
- FDA decisions: 2 (2019–2026): 2 510(k) clearances
- Product codes: KIF (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 1 (0 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
- Avalon Biomed, Inc.: 1 (https://510kreport.com/company/avalon-biomed)
- Enpuno Co., Ltd.: 1 (https://510kreport.com/company/enpuno)

## Firms that cite its devices most
- Inter-Med, Inc.: 1 (https://510kreport.com/company/inter-med)

## Its most-cited devices
- K181917: MTA2.3 Materials (2019), cited by 1

## Recent decisions
- K253909: NeoPEX™ Pre-Mixed Obturation Paste (Sep 4, 2026)
- K181917: MTA2.3 Materials (Jan 11, 2019)

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