510(k) · Cleared
ClearedEndograph DC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Villa Sistemi Medicali S.P.A. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Aug 1, 2013 as substantially equivalent to K120318 (Vivi S.R.L., 2012) after a 197-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Aug 1, 2013
- Review
- 197 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935046 (1994). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK935046 GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
- 3 generations backK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- 2 generations backK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- 1 generation backK120318 Vivi Ergon-X HFVivi S.R.L. · 2012
- This deviceK130109 Endograph DCVilla Sistemi Medicali S.P.A. · 2013
- Descendant · cites it directly · 0 of its ownK231055 x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark…De Götzen S.R.L. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935046 | GX-770 X-Ray Control, Model 46-404600G4 | Gendex Corp. | 1994 | — |
| −3 | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 | Progeny, Inc. | 2004 | — |
| −2 | K083344 | Heliodent Plus | Sirona Dental Systems GmbH | 2008 | — |
| −1 | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| 0 (this device) | K130109 | Endograph DC | Villa Sistemi Medicali S.P.A. | 2013 | — |
| +1 | K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark… | De Götzen S.R.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K120318 | Vivi Ergon-X HFSummary page 1…Predicate Device: The Endograph DC is compared with the following predicate device: . ViVi SrI. Ergon-X HF (K(120318), Product Description: Endlograph DC is an extraoral source x-ray unit. Endlograp… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | 2023 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K231055 (De Götzen S.R.L., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120318.
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. 2013, 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?
Endograph DC is an extracral source x-ray unit for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals. It can be used with both pediatric and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130109 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130109: Endograph DC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130109
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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