510(k) · Cleared
ClearedSpectra Fluorescence Caries Detection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Techniques, Inc. · NBL Light-Induced Fluorescence Caries Detector
Cleared on Aug 18, 2009 as substantially equivalent to K040063 (Inspektor Dental Care BV, 2004) after a 207-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Aug 18, 2009
- Review
- 207 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN990002 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN990002 Kavo DiagnodentKavo America · 2000
- 1 generation backK040063 Inspektor ProInspektor Dental Care BV · 2004
- This deviceK090169 Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK150672 VistaCam iX ProofDurr Dental AG · 2016
- Descendant · 2 generations on · 1 of its ownK221249 L1P-1F (Trios 5)3Shape TRIOS A/S · 2022
- Descendant · 2 generations on · 1 of its ownK171007 Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK252464 Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK242103 TRIOS Ready Tip3Shape TRIOS A/S · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150672VistaCam iX ProofDurr Dental AG · 2016 · cites it directly5descendants
- K221249L1P-1F (Trios 5)3Shape TRIOS A/S · 2022 · 2 generations on1descendant
- K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018 · 2 generations on1descendant
- K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd. · 2026 · 3 generations on0descendants
- K242103TRIOS Ready Tip3Shape TRIOS A/S · 2025 · 3 generations on0descendants
View 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) | K090169 | Spectra Fluorescence Caries Detection Device | Air Techniques, Inc. | 2009 | — |
| +1 | K150672 | VistaCam iX Proof | Durr Dental AG | 2016 | — |
| +2 | K221249 | L1P-1F (Trios 5) | 3Shape TRIOS A/S | 2022 | — |
| +2 | K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 2018 | — |
| +3 | K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | 2026 | — |
| +3 | K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 12.4 · 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 |
|---|---|---|---|
| * | K040063 | Inspektor ProSummary page 1…Classification: Class II, 21 CFR 872.1745 Product Code: NBL 3. Predicate Device Information: Inspektor Pro 51 0(k)# K040063 Inspector Dental Care, Amsterdam, Netherlands 4. Device Description: The Spectra Fluorescence Caries Detection Aid… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150672 | VistaCam iX Proof | 2016 | 5 |
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 9 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150672 (Durr Dental AG, 2016) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K040063.
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. 2009, 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?
Spectra Fluorescence Caries Detection Aid System is indicated as an aid in the
detection and diagnosis of dental caries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090169: Spectra Fluorescence Caries Detection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090169
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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