510(k) · Cleared
ClearedFluorescence Mode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Suzhou Co., Ltd. · NBL Light-Induced Fluorescence Caries Detector
Cleared on May 3, 2018 as substantially equivalent to K150672 (Durr Dental AG, 2016) after a 394-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- May 3, 2018
- Review
- 394 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN990002 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN990002 Kavo DiagnodentKavo America · 2000
- 3 generations backK040063 Inspektor ProInspektor Dental Care BV · 2004
- 2 generations backK090169 Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc. · 2009
- 1 generation backK150672 VistaCam iX ProofDurr Dental AG · 2016
- This deviceK171007 Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK252464 Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN990002 | Kavo Diagnodent | Kavo America | 2000 | — |
| −3 | K040063 | Inspektor Pro | Inspektor Dental Care BV | 2004 | — |
| −2 | K090169 | Spectra Fluorescence Caries Detection Device | Air Techniques, Inc. | 2009 | — |
| −1 | K150672 | VistaCam iX Proof | Durr Dental AG | 2016 | — |
| 0 (this device) | K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 2018 | — |
| +1 | K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K150672 | VistaCam iX ProofSummary page 5…07 2 of 6 PREDICATE DEVICE Company: Durr Dental AG Device: VistaCam iX “Proof” (K150672) It is the opinion of Carl Zeiss Suzhou Company, Limited that the dental Fluorescence Mode of the EXTARO 300 surgical microscope… | 2016 |
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 |
|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380) | 2026 | 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 18 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252464 (Zumax Medical Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150672.
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. 2018, 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 Fluorescence Mode is intended to be used by dentist as an aid in the detection of dental caries
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/K171007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K171007: Fluorescence Mode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K171007
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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