510(k) · Cleared
ClearedDentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentist IN A Box Pty., Ltd. · EMB Zinc Oxide Eugenol
Cleared on Jun 12, 2012 as substantially equivalent to K875133 (Espe GmbH (Us), 1988) after a 97-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jun 12, 2012
- Review
- 97 days
- Class
- Class I
- Product code
- EMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K875133 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK875133 Cavit-WEspe GmbH (Us) · 1988
- This deviceK120695 Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care KitDentist IN A Box Pty., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875133 | Cavit-W | Espe GmbH (Us) | 1988 | — |
| 0 (this device) | K120695 | Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit | Dentist IN A Box Pty., Ltd. | 2012 | — |
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 EMB? 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? (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 |
|---|---|---|---|
| * | K875133 | Cavit-WSummary page 1…evice subject to a predicate in the Convenience Kit and is it's own predicate; Cavit-W temporary crown and bridge resin K8751 33. It is assembled into the kit as packaged from the manufacturer. Device Description and Predicate Devic… | 1988 |
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.
- 2 other devices also cite its predicate K875133.
How does its category compare?
All EMB devicesEMB Zinc Oxide Eugenol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EMB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · EMB
Too few EMB 510(k)s in any year since 2007 to give a median.
Recalls per year · EMB
No recall names EMB since 2007.
Adverse event reports per year · EMB
3in 2025
MAUDE reports naming product code EMB, 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 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dentist In A Box m Dental Emergency Kit Plus Tooth Trauma Care Kit provides immediate, temporary relief from common dental problems, accidents and trauma until a dentist can be seen. For use by trained professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120695 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120695: Dentist in a Box Dental Emergency Kit Plus Tooth Trauma Care Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120695
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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