510(k) · Cleared
ClearedHeliodent DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pelton & Crane Co. · EAP Unit, X-Ray, Intraoral
Cleared on Mar 29, 1996 after a 29-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Mar 29, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- EAP
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK960819 Heliodent DSPelton & Crane Co. · 1996
- Descendant · cites it directly · 9 of its ownK083344 Heliodent PlusSirona Dental Systems GmbH · 2008
- 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
- Descendant · 4 generations on · 3 of its ownK182206 RiX70 DCTrident S.R.L · 2018
- Descendant · cites it directly · 2 of its ownK042260 Phot-X II, Model 303Takara Belmont USA, Inc. · 2004
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 · 2 generations on7descendants
- K163519RX DCCefla S.C. · 2017 · 3 generations on4descendants
- K182206RiX70 DCTrident S.R.L · 2018 · 4 generations on3descendants
- K042260Phot-X II, Model 303Takara Belmont USA, Inc. · 2004 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960819 | Heliodent DS | Pelton & Crane Co. | 1996 | — |
| +1 | K083344 | Heliodent Plus | Sirona Dental Systems GmbH | 2008 | — |
| +2 | K120318 | Vivi Ergon-X HF | Vivi S.R.L. | 2012 | — |
| +3 | K163519 | RX DC | Cefla S.C. | 2017 | — |
| +4 | K182206 | RiX70 DC | Trident S.R.L | 2018 | — |
| +1 | K042260 | Phot-X II, Model 303 | Takara Belmont USA, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 133 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?
- Of its descendants, K083344 (Sirona Dental Systems GmbH, 2008) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EAP devicesEAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EAP
Too few EAP 510(k)s in any year since 2007 to give a median.
Recalls per year · EAP
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAP
1in 2025
MAUDE reports naming product code EAP, 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 | 0 | — | 0 | 6 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K960819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960819: Heliodent DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960819
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026