# NEI: Prosthesis, Condyle, Mandibular, Temporary

- Device class: 2; regulation: 21 CFR 872.4770; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1999: 1
- 2001: 2
- 2004: 1
- 2007: 1
- 2008: 1
- 2014: 1

## Most-cited predicates
- K990667: KLS-Martin Temporary Condylar Implant (2001), cited by 3
- K990637: Synthes Locking Reconstruction Plate (LRP) with Condylar Head (1999), cited by 2
- K002790: Add-on Condyle (2001), cited by 1
- K063181: Synthes (Usa) Condylar Head Add-on System (2007), cited by 1
- K081747: Modification to Synthes (Usa) Condylar Head Add-on System (2008), cited by 1

Source page: https://510kreport.com/product-code/NEI
Data by year (CSV): https://510kreport.com/product-code/NEI.csv