# K083344: Heliodent Plus

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Dec 23, 2008 after 40 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
Longest line of descent: 2 generations back to K935046 (1994). 4 ancestors in all.
9 later devices descend from it; 2 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)
- K960819: Heliodent DS, Pelton & Crane Co. (1996) Summary page 1.
- K043092: Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015, Progeny, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K211014: Portray (2021), 1 descendant of its own
- K130109: Endograph DC (2013), 1 descendant of its own

## Indications for use
The HELIODENT Plus is an extraoral X-Ray source System intended to be used for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K083344
Methodology: https://510kreport.com/methodology