510(k) · Cleared

Cleared

Soprocare

K121685510(k) TraditionalCleared Mar 12, 2013278-day reviewClass II21 CFR 872.1745

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

Sopro · NBL Light-Induced Fluorescence Caries Detector

Cleared on Mar 12, 2013 as substantially equivalent to K092583 (Sopro, 2010) after a 278-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.

Decided: Mar 12, 2013
Review: 278 days
Class: Class II
Product code: NBL
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN990002 (2000). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backDEN990002 Kavo DiagnodentKavo America · 2000
2 generations backK040063 Inspektor ProInspektor Dental Care BV · 2004
1 generation backK092583 SoprolifeSopro · 2010
This deviceK121685 SoprocareSopro · 2013
Descendant · cites it directly · 0 of its ownK223470 C50Sopro · 2023

Most influential descendants

Showing 1 of 1 · See all

K223470C50Sopro · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	DEN990002	Kavo Diagnodent	Kavo America	2000	—
−2	K040063	Inspektor Pro	Inspektor Dental Care BV	2004	—
−1	K092583	Soprolife	Sopro	2010	—
0 (this device)	K121685	Soprocare	Sopro	2013	—
+1	K223470	C50	Sopro	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K121685, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 12.5 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K092583	Soprolife Summary page 2 …Date Cleared Trade Name Manufacturer Code 510(k) number. SOPROLIFE SOPRO NAL K092583 Jauay13 GC Tri Plague ID Gel GO CORPS NYH Not required NA PROBE,…	Sopro	2010	—
*	—	GC Tri Plaque ID Gel Named without a submission number			—
*	—	AESCULAP AG Periodontic probe Named without a submission number			—

Also cleared against K092583: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K223470	C50	Sopro	2023	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 13 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K223470 (Sopro, 2023) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K092583.

How does its category compare?

All NBL devices

NBL Light-Induced Fluorescence Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NBL

1in 2025

2007high 2 (2009) · low 0 (2008)2026

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

2007high 1 (2015) · low 0 (2007)2025

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	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	2	—	0
2010	2	—	0
2011	1	—	0
2012	2	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	1
2016	1	—	1
2017	1	—	1
2018	1	—	0
2019	0	—	0
2020	1	—	1
2021	0	—	0
2022	1	—	0
2023	1	—	0
2024	2	—	0
2025	1	—	0
2026	1	—	—

What is it indicated for?

The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflaminationis (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invibe to the naked eye or with a mirror (thanks to its magnification).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121685 · printed Nov 4, 2026

Cite this page

510(k) Report. “K121685: Soprocare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121685

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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