510(k) · Cleared
ClearedInspektor Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inspektor Dental Care BV · NBL Light-Induced Fluorescence Caries Detector
Cleared on Jun 24, 2004 as substantially equivalent to DEN990002 (Kavo America, 2000) after a 163-day review. Its family tree reaches back 1 generation to 2000. 13 later devices descend from it.
- Decided
- Jun 24, 2004
- Review
- 163 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN990002 (2000). 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backDEN990002 Kavo DiagnodentKavo America · 2000
- This deviceK040063 Inspektor ProInspektor Dental Care BV · 2004
- Descendant · cites it directly · 6 of its ownK090169 Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK150672 VistaCam iX ProofDurr Dental AG · 2016
- Descendant · cites it directly · 3 of its ownK092583 SoprolifeSopro · 2010
- Descendant · 3 generations on · 1 of its ownK221249 L1P-1F (Trios 5)3Shape TRIOS A/S · 2022
- Descendant · 3 generations on · 1 of its ownK171007 Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090169Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc. · 2009 · cites it directly6descendants
- K150672VistaCam iX ProofDurr Dental AG · 2016 · 2 generations on5descendants
- K092583SoprolifeSopro · 2010 · cites it directly3descendants
- K221249L1P-1F (Trios 5)3Shape TRIOS A/S · 2022 · 3 generations on1descendant
- K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN990002 | Kavo Diagnodent | Kavo America | 2000 | — |
| 0 (this device) | K040063 | Inspektor Pro | Inspektor Dental Care BV | 2004 | — |
| +1 | K090169 | Spectra Fluorescence Caries Detection Device | Air Techniques, Inc. | 2009 | — |
| +2 | K150672 | VistaCam iX Proof | Durr Dental AG | 2016 | — |
| +1 | K092583 | Soprolife | Sopro | 2010 | — |
| +3 | K221249 | L1P-1F (Trios 5) | 3Shape TRIOS A/S | 2022 | — |
| +3 | K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | DEN990002 | Kavo Diagnodent Our reading of the summary gave K983658, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990002, Kavo Diagnodent (Kavo America), granted Feb 22, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2000 |
What descends from it? (13)
See all 135 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.
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 InspektorTM Pro is indicated as an aid in the diagnosis of dental caries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040063: Inspektor Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040063
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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