510(k) · Cleared
ClearedPreva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progeny, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Dec 13, 2004 as substantially equivalent to K935046 (Gendex Corp., 1994) and 1 other predicate after a 34-day review. Its family tree reaches back 1 generation to 1994. 13 later devices descend from it.
- Decided
- Dec 13, 2004
- Review
- 34 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935046 (1994). 2 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK935046 GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
- This deviceK043092 Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015Progeny, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK083344 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 · cites it directly · 2 of its ownK103579 Intra Skan DCSkanray Technologies · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K083344Heliodent PlusSirona Dental Systems GmbH · 2008 · cites it directly9descendants
- 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
- K103579Intra Skan DCSkanray Technologies · 2011 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935046 | GX-770 X-Ray Control, Model 46-404600G4 | Gendex Corp. | 1994 | — |
| 0 (this device) | K043092 | Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015 | Progeny, Inc. | 2004 | — |
| +1 | 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 | — |
| +1 | K103579 | Intra Skan DC | Skanray Technologies | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K935046 | GX-770 X-Ray Control, Model 46-404600G4Summary page 2…ry. There are several major independent manufacturers of Intra Oral diagnostic Radiographic Systems on the U.S. market. One is the Dentsply Gx770. The 5 10(k) number is K935046. The classification of the Dentsply device is listed as product code 76EHD. The other currently marketed device is the Gendex 76… | 1994 |
| * | K992610 | Gendex 765DC, Model 110-0154Summary page 2…fication of the Dentsply device is listed as product code 76EHD. The other currently marketed device is the Gendex 765, manufactured by Dentsply, Inc. the 510(k)numberisK992610. The classification of the Gendex 765 is listed as product code 76EHD. Labeling for the currently marketed devices is included a… | 1999 |
What descends from it? (13)
See all 135 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?
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 intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043092 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043092: Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043092
Report an extraction error
Are you the manufacturer?
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