# PLV: Dental Stereotaxic Instrument

- Device class: 2; regulation: 21 CFR 872.4120; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 130 days (middle half 116–287)
- Recalls: 2 (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)
- 2015: 1
- 2016: 2
- 2018: 2
- 2019: 2
- 2020: 7
- 2021: 2
- 2022: 3
- 2023: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- K150222: X-Guide Surgical Navigation System (2015), cited by 6
- K161399: Neocis Guidance System (2016), cited by 3
- K173402: Neocis Guidance System (NGS) with Chairside Splint (2018), cited by 3
- K202264: Neocis Guidance System (NGS) with Yomi Plan v2.0 (2020), cited by 2
- K231018: Yomi Robotic System (2023), cited by 2
- K182776: Neocis Guidance System (2018), cited by 2
- K161406: Navident (2016), cited by 1
- K200805: Neocis Guidance System (NGS) with Patient Splints (2020), cited by 1
- K210711: Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (2021), cited by 1
- K192579: X-Guide Surgical Navigation System (2020), cited by 1

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