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 · LWM Device, Electrical Dental Anesthesia
Cleared on Jan 14, 2020 as substantially equivalent to K182947 (Synapse Dental, LLC, 2019) after a 131-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jan 14, 2020
- Review
- 131 days
- Class
- Class U
- Product code
- LWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915717 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 |
|---|---|---|---|
| * | K182947 | Dental Pain EraserSummary page 4…me: Device, Electrical Dental Anesthesia Classification: Unclassified, Pre-Amendment Product Code: LWM PREDICATE DEVICE(S) [807.92(A)(3)] Dental Pain Eraser DPE-C300 (K182947) DEVICE DESCRIPTION [807.92(A)(4)] The Dental Pain Eraser DPE-T300 is a non-invasive electrical stimulation device that is used… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 26.3 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K182947.
How does its category compare?
All LWM devicesLWM Device, Electrical Dental Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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-T300 is intended to provide temporary dental anesthesia (pain relief). It is intended for prescriptive use only for the alleviation of oral pain for use by pediatric (10 years through 22 years of age) and adult patients for treatment at home. Pediatric patients 10 through 12 years of age must be supervised by an adult.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192429: Dental Pain Eraser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192429
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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