# K050019: IN Exam Intraoral Dental X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Kavo America
- Decided: Jan 31, 2005 after 26 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gendex 765DC: named in the summary without a submission number
- (no number) Planmeca Prostyle Intra: named in the summary without a submission number
- (no number) Trophy Elitys: named in the summary without a submission number

## Most influential descendants
- K063321: D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138 (2007), 0 descendants of its own

## Indications for use
The KaVo In exam Intraod X-ray device is to be used exclusively within dentisby as an extraoral source of x-rays.

Source page: https://510kreport.com/device/K050019
Methodology: https://510kreport.com/methodology