510(k) · Cleared
ClearedHeliodent Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Dec 23, 2008 as substantially equivalent to K960819 (Pelton & Crane Co., 1996) and 1 other predicate after a 40-day review. Its family tree reaches back 2 generations to 1994. 9 later devices descend from it.
- Decided
- Dec 23, 2008
- Review
- 40 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935046 (1994). 4 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935046 GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
- 1 generation backK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- This deviceK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- Descendant · cites it directly · 7 of its ownK120318 Vivi Ergon-X HFVivi S.R.L. · 2012
- Descendant · 2 generations on · 4 of its ownK163519 RX DCCefla S.C. · 2017
- Descendant · 3 generations on · 3 of its ownK182206 RiX70 DCTrident S.R.L · 2018
- Descendant · 4 generations on · 1 of its ownK211014 PortraySurround Medical Systems · 2021
- Descendant · 2 generations on · 1 of its ownK130109 Endograph DCVilla Sistemi Medicali S.P.A. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120318Vivi Ergon-X HFVivi S.R.L. · 2012 · cites it directly7descendants
- K163519RX DCCefla S.C. · 2017 · 2 generations on4descendants
- K182206RiX70 DCTrident S.R.L · 2018 · 3 generations on3descendants
- K211014PortraySurround Medical Systems · 2021 · 4 generations on1descendant
- K130109Endograph DCVilla Sistemi Medicali S.P.A. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935046 | GX-770 X-Ray Control, Model 46-404600G4 | Gendex Corp. | 1994 | — |
| −1 | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 | Progeny, Inc. | 2004 | — |
| 0 (this device) | K083344 | Heliodent Plus | Sirona Dental Systems GmbH | 2008 | — |
| +1 | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| +2 | K163519 | RX DC | Cefla S.C. | 2017 | — |
| +3 | K182206 | RiX70 DC | Trident S.R.L | 2018 | — |
| +4 | K211014 | Portray | Surround Medical Systems | 2021 | — |
| +2 | K130109 | Endograph DC | Villa Sistemi Medicali S.P.A. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EHD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960819 | Heliodent DSSummary page 1…/Usual Name: Unit, X-Ray, Extraoral with Timer Classification Names: Extraoral source x-ray system 3. PREDICATE DEVICE Sirona HELIODENT DS (K960819) and Progeny Preva Dental X-Ray System (K043092) 4. INTENDED USE The HELIODENT Plus is an extraoral X-Ray source… | 1996 |
| * | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Summary page 1…Classification Names: Extraoral source x-ray system 3. PREDICATE DEVICE Sirona HELIODENT DS (K960819) and Progeny Preva Dental X-Ray System (K043092) 4. INTENDED USE The HELIODENT Plus is an extraoral X-Ray source System intended to be used for dental radiograp… | 2004 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K120318 (Vivi S.R.L., 2012) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K960819.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083344: Heliodent Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083344
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026