# K212103: StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2

- Pathway: 510(k) (Traditional)
- Applicant: Fona S.R.L
- Decided: Aug 30, 2021 after 55 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
Longest line of descent: 6 generations back to K933455 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151926: QuickRay HD Intraoral Sensor, Denterprise International, Inc. (2015) Summary page 4.

## Indications for use
Acquisition of intraoral X-Ray image of the human dental arch. In particular: » The STARX-1/ STARX PRO-1 sensors (active area 20 x 30 mm) allow to acquire the majority of intraoral images both vertically and horizontally. » The STARX-2/ STARX PRO-2 sensors (active area 26 x 34 mm) allow to acquire horizontal bitewing images.

Source page: https://510kreport.com/device/K212103
Methodology: https://510kreport.com/methodology