510(k) · Cleared

Cleared

Caries Detector

K951813510(k) TraditionalCleared Jul 11, 199584-day reviewClass II21 CFR 872.1740

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kuraray Co. · LFC Device, Caries Detection

Cleared on Jul 11, 1995 after an 84-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: Jul 11, 1995
Review: 84 days
Class: Class II
Product code: LFC
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK951813 Caries DetectorKuraray Co. · 1995
Descendant · cites it directly · 1 of its ownK012733 Caries DetectorKuraray Medical, Inc. · 2001
Descendant · 2 generations on · 0 of its ownK102821 DiscovredPhoenix Dental, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all

K012733Caries DetectorKuraray Medical, Inc. · 2001 · cites it directly1descendant
K102821DiscovredPhoenix Dental, Inc. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K951813	Caries Detector	Kuraray Co.	1995	—
+1	K012733	Caries Detector	Kuraray Medical, Inc.	2001	—
+2	K102821	Discovred	Phoenix Dental, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2011	1	0

FIG. 1 — Lineage of K951813, 1995–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012733	Caries Detector	Kuraray Medical, Inc.	2001	1

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?

Of its descendants, K012733 (Kuraray Medical, Inc., 2001) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LFC devices

LFC Device, Caries Detection: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFC

1in 2023

2007high 1 (2011) · low 0 (2007)2026

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

2007high 1 (2009) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	1
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	0
2021	1	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K951813 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951813: Caries Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951813

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026