# EIH: Powder, Porcelain

- Device class: 2; regulation: 21 CFR 872.6660; FDA's rule: 510(k) required
- FDA decisions: 489
- 510(k) review time 2021–2025: median 91 days (middle half 66–165)
- Recalls: 22 (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: 16
- 2018: 10
- 2019: 16
- 2020: 13
- 2021: 17
- 2022: 16
- 2023: 15
- 2024: 28
- 2025: 13
- 2026: 14

## Most-cited predicates
- K051705: Ips E.Max Cad/Ips E.Max Zircad (2005), cited by 21
- K141724: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (2014), cited by 15
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram (2001), cited by 15
- K013230: Cercon Base (2001), cited by 15
- K022996: Vita in-Ceram YZ Cubes for Cerec (2002), cited by 9
- K062695: Sagemax Z-Blank (2006), cited by 8
- K984201: Denzir (1999), cited by 8
- K072569: Metoxit Cam-Blanks (2007), cited by 6
- K023327: Cynovad Zirkon (2002), cited by 6
- K112710: Zenotec ZR Bridge, Zenostar ZR Translucent, Zenotec Color ZR, Zenostar Color ZR (2011), cited by 6

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