510(k) · Cleared
ClearedDentalJect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vapocoolshot, Inc. · MLY Vapocoolant Device
Cleared on May 30, 2025 as substantially equivalent to K011666 (Heatshield, Inc., 2001) after a 185-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 30, 2025
- Review
- 185 days
- Class
- Class U
- Product code
- MLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011666 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011666 ChillitHeatshield, Inc. · 2001
- This deviceK243654 DentalJectVapocoolshot, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011666 | Chillit | Heatshield, Inc. | 2001 | — |
| 0 (this device) | K243654 | DentalJect | Vapocoolshot, Inc. | 2025 | — |
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 MLY? 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 MLY device
- #1 K260870 Gebauer's Pain Ease Topical Anesthetic Skin…score 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K011666 | ChillitSummary page 5…n Number: Unclassified Classification Name: Vapocoolant Device Device Class: Unclassified Predicate and Reference Device Information Primary Predicate: K011666 Trade/ Device Name : Chillit Regulation Number : 872.1720 Classification Product code: EAT Subsequent Pro… | 2001 |
| † | K201248 | Syringe Holder accessory | 2020 |
| † | K232674 | PainFreeze II | 2024 |
| † | K193349 | Vapocoolshot Mist | 2020 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MLY devicesMLY Vapocoolant Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MLY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLY
93in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLY
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLY
4in 2025
MAUDE reports naming product code MLY, 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 | — | 6 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 3 | 93 | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The DentalJect™ is intended for topical application to intact mucous membrane (oral cavity). The DentalJect™ is used to target a minimally sized cooling area for lessening pain associated with injections.
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/K243654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243654: DentalJect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243654
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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