# 3D Smile USA, Inc.

- Location (FDA's records): Philadelphia, PA
- FDA decisions: 1 (2020–2020): 1 510(k) clearance
- Product codes: NXC (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (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
- Osw Manufacturing, LLC: 1 (https://510kreport.com/company/osw-manufacturing)
- Ortho Caps GmbH: 1 (https://510kreport.com/company/ortho-caps)

## Recent decisions
- K200214: 3D Predict (Feb 24, 2020)

Source page: https://510kreport.com/company/3d-smile-usa