# NHA: Abutment, Implant, Dental, Endosseous

- Device class: 2; regulation: 21 CFR 872.3630; FDA's rule: 510(k) required
- FDA decisions: 716
- 510(k) review time 2021–2025: median 158 days (middle half 95–243)
- Recalls: 64 (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: 31
- 2018: 31
- 2019: 28
- 2020: 38
- 2021: 29
- 2022: 33
- 2023: 51
- 2024: 43
- 2025: 40
- 2026: 23

## Most-cited predicates
- K072570: Nobelactive Multi Unit Abutment (2007), cited by 18
- K170588: DESS Dental Smart Solutions (2017), cited by 16
- K150203: Medentika CAD/CAM Abutments (2015), cited by 14
- K161689: OSSTEM Implant System - Abutment (2017), cited by 13
- K072642: Biomet 3I Dental Abutments and Restorative Components (2007), cited by 12
- K182091: Osstem Abutment System (2019), cited by 11
- K052957: Implantium Prosthetics (2006), cited by 10
- K081575: HU/HS/HG Prosthetic System (2008), cited by 10
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), cited by 10
- K161416: Multi-unit Abutment Plus (2017), cited by 10

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