# EAP: Unit, X-Ray, Intraoral

- Device class: 2; regulation: 21 CFR 872.1810; FDA's rule: 510(k) required
- FDA decisions: 42
- Recalls: 3 (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)
- 1993: 5
- 1994: 3
- 1995: 7
- 1996: 2
- 2004: 1
- 2005: 1
- 2008: 1
- 2009: 1
- 2011: 1
- 2012: 1

## Most-cited predicates
- K933455: Computed Oral Radiology System (1994), cited by 10
- K041385: Modification to Computed Oral Radiology System (2004), cited by 3
- K960819: Heliodent DS (1996), cited by 3
- K950533: Trophy Radiologie RVG Radiovisiography (1995), cited by 2
- K950532: Trophy Radiologie RVG Portable Radiovisiography (1995), cited by 2
- K950667: Aztech 65 with CCD (Computer Controlled Density) Timer (1995), cited by 1
- K900681: Panoramic Model X-Caliber X-Ray (1990), cited by 1
- K896024: MDT/Castle Model HDX Dental X-Ray Machine (1990), cited by 1
- K113360: Medical Image Processing Unit (2012), cited by 1
- K080738: Dentron Sensor (2008), cited by 1

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