# DZE: Implant, Endosseous, Root-Form

- Device class: 2; regulation: 21 CFR 872.3640; FDA's rule: 510(k) required
- FDA decisions: 1,551
- 510(k) review time 2021–2025: median 216 days (middle half 134–302)
- Recalls: 103 (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)
- 2017: 48
- 2018: 41
- 2019: 31
- 2020: 41
- 2021: 34
- 2022: 34
- 2023: 35
- 2024: 40
- 2025: 31
- 2026: 15

## Most-cited predicates
- K062129: P.0004 Implants (2006), cited by 31
- K071370: Nobelactive Internal Connection Implant (2007), cited by 29
- K120414: Osseospeed Plus (2012), cited by 27
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX (2003), cited by 23
- K040807: Mis Dental Implant System (2004), cited by 22
- K022562: Various Branemark System Implants-Immediate Function Indication (2002), cited by 19
- K023113: Replace Tiunite Endosseous Implant (2002), cited by 17
- K033767: Dual Top Anchor System Screws (2004), cited by 17
- K050406: Nobelspeedy Implants (2005), cited by 16
- K011028: Screw-Vent Dental Implant System (2001), cited by 16

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