# FZE: Prosthesis, Nose, Internal

- Device class: 2; regulation: 21 CFR 878.3680; FDA's rule: 510(k) required
- FDA decisions: 42
- 510(k) review time 2021–2025: median 223 days (middle half 223–223)
- 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)
- 1997: 2
- 1998: 3
- 1999: 1
- 2002: 1
- 2005: 1
- 2007: 1
- 2009: 1
- 2010: 1
- 2016: 1
- 2024: 1

## Most-cited predicates
- K945154: BA-Cpas (1995), cited by 5
- K952707: Silicone Elastomer Malar Implant (1995), cited by 2
- K090630: Nobel Biocare Endosseous Implants (Maxillofacial Indication) (2009), cited by 1
- K971481: Duralastic Anatomical Nasal Implants (1997), cited by 1
- K161548: Osseointegrated Fixtures (2016), cited by 1
- K983755: Nasal Dorsal Series (1998), cited by 1
- K973573: Duralastic Anatomical Nasal Implants (1997), cited by 1
- K952705: Spirit Ridge Nasal Implant (1995), cited by 1
- K952708: Pectoralis Implant (1995), cited by 1

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