510(k) · Cleared
ClearedSoprolife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sopro · NBL Light-Induced Fluorescence Caries Detector
Cleared on Jan 13, 2010 as substantially equivalent to K040063 (Inspektor Dental Care BV, 2004) and 1 other predicate after a 145-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Jan 13, 2010
- Review
- 145 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN990002 (2000). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN990002 Kavo DiagnodentKavo America · 2000
- 1 generation backK040063 Inspektor ProInspektor Dental Care BV · 2004
- This deviceK092583 SoprolifeSopro · 2010
- Descendant · cites it directly · 1 of its ownK121685 SoprocareSopro · 2013
- Descendant · 2 generations on · 0 of its ownK223470 C50Sopro · 2023
- Descendant · cites it directly · 0 of its ownK111423 CS 1600 Intraoral CameraCarestream Health, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN990002 | Kavo Diagnodent | Kavo America | 2000 | — |
| −1 | K040063 | Inspektor Pro | Inspektor Dental Care BV | 2004 | — |
| 0 (this device) | K092583 | Soprolife | Sopro | 2010 | — |
| +1 | K121685 | Soprocare | Sopro | 2013 | — |
| +2 | K223470 | C50 | Sopro | 2023 | — |
| +1 | K111423 | CS 1600 Intraoral Camera | Carestream Health, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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 12.5 · 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 |
|---|---|---|---|
| * | K040063 | Inspektor ProSummary page 2…ye or with mirror. G. -SubstantialEquivalence The SOPROLIFE (in Diagnosis aid mode and inTreatment aid mode) and the predicate device, INSPEKTOR PRO (K040063), are bath fluorescence caries detection device for use in dentistry by qualified physicians, to aid in the diagnosis of… | 2004 |
| * | K012505 | SOPRO595 Intra Oral CameraSummary page 1…eared INSPEKTOR PRO INSPEKTOR Dental Care BV K(040063 June 24, 2004 SOPRO 595 SOPRO K012505 October 5, 2001 The SOPROLIFE is substantially equivalent to the predicate device by INSPEKTOR… | 2001 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2010, 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 SOPROLIFE is indicated as an aid in the diagnosis of dental caries and as an intra oral camera to visualize anatomical details Invisible to the naked eye or with mirror.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092583: Soprolife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092583
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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