# K994285: Orthoralix 9200, Orthoralix 9200 Plus, Orthoralix 9200 Ceph, Orthoralix 9200 Plus Ceph

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Mar 14, 2000 after 85 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Pelton & Crane Orthophos Plus: named in the summary without a submission number
- (no number) Planmeca PM 2002 CC Proline: named in the summary without a submission number
- (no number) Instrumentarium Imaging Orthorpantomograph® OPD: named in the summary without a submission number
- (no number) Gendex Orthoralix SD2/Ceph and S/Ceph: named in the summary without a submission number

## Indications for use
The Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.

Source page: https://510kreport.com/device/K994285
Methodology: https://510kreport.com/methodology