510(k) · Cleared
Recalled · Class II · 2014Gendex 765DC, Model 110-0154
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 7, 1999 after a 34-day review. The FDA summary names its predicate without a number. 15 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 7, 1999
- Review
- 34 days
- Class
- Class II
- Product code
- EHD
- Recalls
- 4
- Predicates
- 0
15 later devices descend from it, 4 citing it directly.
- This deviceK992610 Gendex 765DC, Model 110-0154Dentsply Intl. · 1999
- Descendant · cites it directly · 13 of its ownK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- Descendant · 2 generations on · 9 of its ownK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- Descendant · cites it directly · 8 of its ownK030634 Endos DCVilla Sistemi Medicali S.P.A. · 2003
- Descendant · 2 generations on · 7 of its ownK120318 Vivi Ergon-X HFVivi S.R.L. · 2012
- Descendant · 3 generations on · 4 of its ownK163519 RX DCCefla S.C. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K043092Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004 · cites it directly13descendants
- K083344Heliodent PlusSirona Dental Systems GmbH · 2008 · 2 generations on9descendants
- K030634Endos DCVilla Sistemi Medicali S.P.A. · 2003 · cites it directly8descendants
- K120318Vivi Ergon-X HFVivi S.R.L. · 2012 · 2 generations on7descendants
- K163519RX DCCefla S.C. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992610 | Gendex 765DC, Model 110-0154 | Dentsply Intl. | 1999 | — |
| +1 | 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 | K030634 | Endos DC | Villa Sistemi Medicali S.P.A. | 2003 | — |
| +2 | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| +3 | K163519 | RX DC | Cefla S.C. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | — | Sirona Heliodent DS Named without a submission number | |
| * | — | Planmeca Prostyle Intra Named without a submission number | |
| * | — | Gendex GX-DC Named without a submission number | |
| * | — | Gendex GX-770 Named without a submission number |
What descends from it? (15)
See all 154 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2014 | Class II | Z-0009-2015 | Nonconforming Material/Component | Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being… |
| Dec 29, 2011 | Not classified | Z-1358-2012 | Nonconforming Material/Component | Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly. |
| Dec 20, 2010 | Not classified | Z-1559-2011 | Nonconforming Material/Component | The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate. |
| Dec 17, 2010 | Not classified | Z-1248-2011 | Component design/selection | The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043092 (Progeny, Inc., 2004) has gone furthest, with 13 descendants of its own.
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?
The Gendex 765DC Intraoral Dental X-Ray System is to be used as an extraoral
source of x-rays in Dental Radiography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992610: Gendex 765DC, Model 110-0154.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992610
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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