510(k) · Cleared
ClearedEndos 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 Jul 21, 2003 as substantially equivalent to K992610 (Dentsply Intl., 1999) after a 144-day review. Its family tree reaches back 1 generation to 1999. 8 later devices descend from it.
- Decided
- Jul 21, 2003
- Review
- 144 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992610 (1999). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992610 Gendex 765DC, Model 110-0154Dentsply Intl. · 1999 · Recalled
- This deviceK030634 Endos DCVilla Sistemi Medicali S.P.A. · 2003
- 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| −1 | K992610 | Gendex 765DC, Model 110-0154 | Dentsply Intl. | 1999 | 4 |
| 0 (this device) | K030634 | Endos DC | Villa Sistemi Medicali S.P.A. | 2003 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K992610 | Gendex 765DC, Model 110-0154 Our reading of the summary gave K092610, FDA’s number for Modification to Beacon Stabilization System (Globus Medical, Inc.), decided Sep 24, 2009, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GENDEX DENTSPLY model 765DC”. | 1999 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120318 | Vivi Ergon-X HF | 2012 | 7 |
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?
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.
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?
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030634: Endos DC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030634
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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