# K191616: Orthophos S

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jul 16, 2019 after 28 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K973642 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150217: Orthophos SL, Sirona Dental Systems GmbH (2015) Summary page 5.

## Indications for use
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry and pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures.

Source page: https://510kreport.com/device/K191616
Methodology: https://510kreport.com/methodology