510(k) · Cleared
ClearedCaries Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · LFC Device, Caries Detection
Cleared on Sep 14, 2001 as substantially equivalent to K951813 (Kuraray Co., 1995) and 1 other predicate after a 31-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Sep 14, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- LFC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913405 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K102821DiscovredPhoenix Dental, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913405 | Kar-D-Tek | Gresco Products, Inc. | 1991 | — |
| 0 (this device) | K012733 | Caries Detector | Kuraray Medical, Inc. | 2001 | — |
| +1 | K102821 | Discovred | Phoenix Dental, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 LFC? 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 LFC device
- #1 K222560 BlueCheck™ Caries Detection & Monitoringscore 5.6 · 2 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 |
|---|---|---|---|
| * | K951813 | Caries DetectorSummary page 1…bmission is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CARIES DETECTOR by Kuraray Co., Ltd. (K951813) 2. Kar-D-Tek by Gresco Products Inc. (K913405) 4. Description for the premarket notification This product is classified into C… | 1995 |
| * | K913405 | Kar-D-TekSummary page 1…nufacturer, and not to intend other changes. The predicate device is as follow. 1. CARIES DETECTOR by Kuraray Co., Ltd. (K951813) 2. Kar-D-Tek by Gresco Products Inc. (K913405) 4. Description for the premarket notification This product is classified into Caries Detection Device, CFR 21 Section 872. 174… | 1991 |
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 |
|---|---|---|---|
| K102821 | Discovred | 2011 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K102821 (Phoenix Dental, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LFC devicesLFC Device, Caries Detection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFC
Too few LFC 510(k)s in any year since 2007 to give a median.
Recalls per year · LFC
No recall names LFC since 2007.
Adverse event reports per year · LFC
1in 2009
MAUDE reports naming product code LFC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 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 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CARIES DETECTOR is indicated for the following applications:
1) Detection of carious dentin
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/K012733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012733: 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/K012733
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026