510(k) · Cleared
ClearedCedeta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D-W Intl. · LWM Device, Electrical Dental Anesthesia
Cleared on Nov 23, 1992 after a 340-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Nov 23, 1992
- Review
- 340 days
- Class
- Class U
- Product code
- LWM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK915717 CedetaD-W Intl. · 1992
- Descendant · cites it directly · 2 of its ownK182947 Dental Pain EraserSynapse Dental, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK193570 Dental Pain EraserSynapse Dental · 2020
- Descendant · 2 generations on · 0 of its ownK192429 Dental Pain EraserSynapse Dental · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915717 | Cedeta | D-W Intl. | 1992 | — |
| +1 | K182947 | Dental Pain Eraser | Synapse Dental, LLC | 2019 | — |
| +2 | K193570 | Dental Pain Eraser | Synapse Dental | 2020 | — |
| +2 | K192429 | Dental Pain Eraser | Synapse Dental | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 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 LWM? 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 LWM device
- #1 K193570 Dental Pain Eraserscore -1.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182947 | Dental Pain Eraser | 2019 | 2 |
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, K182947 (Synapse Dental, LLC, 2019) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LWM devicesLWM Device, Electrical Dental Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWM
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · LWM
Too few LWM 510(k)s in any year since 2007 to give a median.
Recalls per year · LWM
No recall names LWM since 2007.
Adverse event reports per year · LWM
No MAUDE report names LWM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K915717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915717: Cedeta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915717
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