510(k) · Cleared
ClearedDental Pain Eraser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synapse Dental, LLC · LWM Device, Electrical Dental Anesthesia
Cleared on Mar 26, 2019 as substantially equivalent to K915717 (D-W Intl., 1992) after a 154-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Mar 26, 2019
- Review
- 154 days
- Class
- Class U
- Product code
- LWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915717 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915717 CedetaD-W Intl. · 1992
- This deviceK182947 Dental Pain EraserSynapse Dental, LLC · 2019
- Descendant · cites it directly · 0 of its ownK193570 Dental Pain EraserSynapse Dental · 2020
- Descendant · cites it directly · 0 of its ownK192429 Dental Pain EraserSynapse Dental · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915717 | Cedeta | D-W Intl. | 1992 | — |
| 0 (this device) | K182947 | Dental Pain Eraser | Synapse Dental, LLC | 2019 | — |
| +1 | K193570 | Dental Pain Eraser | Synapse Dental | 2020 | — |
| +1 | K192429 | Dental Pain Eraser | Synapse Dental | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K915717 | CedetaSummary page 5…A3-2 510(k) SUMMARY PREDICATE DEVICE(S) [807.92(a)(3)] The Dental Pain Eraser is substantially equivalent to the cleared CEDETA Mk2 device (K915717). The devices have the same intended uses, as both are used by dental professionals in the treatment of pain resulting from denta… | 1992 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K193570 (Synapse Dental, 2020) has gone furthest, with 0 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. 2019, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Dental Pain Eraser DPE-C300 is intended to provide temporary dental anesthesia (pain relief) and is indicated for use before, during, or after dental and orthodontic procedures, and other sources of oral pain. It is intended for use by dental/orthodontic professionals for the alleviation of oral pain.
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/K182947 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182947: Dental Pain Eraser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182947
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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