510(k) · Cleared
ClearedElectronic Caries Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortek Therapeutics, Inc. · NBL Light-Induced Fluorescence Caries Detector
Cleared on Sep 11, 2017 as substantially equivalent to K090598 (Cariescan, Ltd., 2009) and 1 other predicate after a 175-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Sep 11, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921979 (1993). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 6 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 5 generations backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- 4 generations backK032743 Apex NRGMedicnrg, Ltd. · 2004
- 3 generations backK063843 Apexnrg XFRMedicnrg, Ltd. · 2007
- 2 generations backK071133 Apexnrg-Blue Electronic Apex LocatorMedicnrg, Ltd. · 2007
- 1 generation backK090598 Cariescan ProCariescan, Ltd. · 2009
- This deviceK170822 Electronic Caries DetectorOrtek Therapeutics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −6 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −5 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| −4 | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| −3 | K063843 | Apexnrg XFR | Medicnrg, Ltd. | 2007 | — |
| −2 | K071133 | Apexnrg-Blue Electronic Apex Locator | Medicnrg, Ltd. | 2007 | — |
| −1 | K090598 | Cariescan Pro | Cariescan, Ltd. | 2009 | — |
| 0 (this device) | K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K090598 | Cariescan ProSummary page 5…Name / Manufacturer Primary Number Predicate K090598 CarieScan Pro – Cariescan LLC K982105 Oral Potential Meter – Perte… | 2009 |
| * | K982105 | Oral Potential Meter (Opm)Summary page 5…Predicate K090598 CarieScan Pro – Cariescan LLC K982105 Oral Potential Meter – Pertec of Wisconsin, Inc. SUMMARY OF NON‐CLINICAL AND CLINICAL TESTING No FDA performance standards h… | 1998 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 10 ancestors has a recall.
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. 2017, 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?
The Electronic Caries Detector is 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/K170822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170822: Electronic Caries Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170822
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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