# Ensmile Pvt, Ltd.

- Location (FDA's records): Johar Town, PK
- FDA decisions: 1 (2023–2023): 1 510(k) clearance
- Product codes: NXC (1)
- Predicates its devices cite: 1 (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
- Align Technology, Inc.: 1 (https://510kreport.com/company/align-technology)

## Firms that cite its devices most
- Dentis Co., Ltd.: 1 (https://510kreport.com/company/dentis)

## Its most-cited devices
- K222619: Ensmile (2023), cited by 1

## Recent decisions
- K222619: Ensmile (Mar 16, 2023)

Source page: https://510kreport.com/company/ensmile-pvt