510(k) · Cleared
ClearedCariescan Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cariescan, Ltd. · NBL Light-Induced Fluorescence Caries Detector
Cleared on Dec 15, 2009 as substantially equivalent to DEN990002 (Kavo America, 2000) and 1 other predicate after a 285-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Dec 15, 2009
- Review
- 285 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921979 (1993). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 5 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 4 generations backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- 3 generations backK032743 Apex NRGMedicnrg, Ltd. · 2004
- 2 generations backK063843 Apexnrg XFRMedicnrg, Ltd. · 2007
- 1 generation backK071133 Apexnrg-Blue Electronic Apex LocatorMedicnrg, Ltd. · 2007
- This deviceK090598 Cariescan ProCariescan, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK170822 Electronic Caries DetectorOrtek Therapeutics, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170822Electronic Caries DetectorOrtek Therapeutics, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −5 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −4 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| −3 | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| −2 | K063843 | Apexnrg XFR | Medicnrg, Ltd. | 2007 | — |
| −1 | K071133 | Apexnrg-Blue Electronic Apex Locator | Medicnrg, Ltd. | 2007 | — |
| 0 (this device) | K090598 | Cariescan Pro | Cariescan, Ltd. | 2009 | — |
| +1 | K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 NBL? 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 NBL device
- #1 K252464 Surgical Microscope (OMS2360, OMS2380)score 12.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | DEN990002 | Kavo Diagnodent Our reading of the summary gave K983658, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990002, Kavo Diagnodent (Kavo America), granted Feb 22, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2000 |
| * | K071133 | Apexnrg-Blue Electronic Apex LocatorSummary page 1…ed devices Performance - DIAGNOdent® 2095 K983658. Safety - Apex NRG XFR, Electronic Apex Locator K071133. 5.5 Indications for Use (intended Use) For use by dental professionals as an aid in the diagnosis and monitoring of dental car… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170822 | Electronic Caries Detector | 2017 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K170822 (Ortek Therapeutics, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate DEN990002.
How does its category compare?
All NBL devicesNBL Light-Induced Fluorescence Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NBL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBL
Too few NBL 510(k)s in any year since 2007 to give a median.
Recalls per year · NBL
No recall names NBL since 2007.
Adverse event reports per year · NBL
1in 2020
MAUDE reports naming product code NBL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090598: Cariescan Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090598
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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