# K960819: Heliodent DS

- Pathway: 510(k) (Traditional)
- Applicant: Pelton & Crane Co.
- Decided: Mar 29, 1996 after 29 days
- Product code: EAP (Unit, X-Ray, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K083344: Heliodent Plus (2008), 9 descendants of its own
- K120318: Vivi Ergon-X HF (2012), 7 descendants of its own
- K163519: RX DC (2017), 4 descendants of its own
- K182206: RiX70 DC (2018), 3 descendants of its own
- K042260: Phot-X II, Model 303 (2004), 2 descendants of its own

Source page: https://510kreport.com/device/K960819
Methodology: https://510kreport.com/methodology