# K990528: Orthophos 3/3 Ceph/3 DS

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Apr 30, 1999 after 70 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073365: Dental Digital X-Ray Imaging System (2008), 1 descendant of its own
- K100317: Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo (2010), 0 descendants of its own

## Indications for use
The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging and teleradiography.

Source page: https://510kreport.com/device/K990528
Methodology: https://510kreport.com/methodology