510(k) · Cleared
ClearedVistaCam iX Proof
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Durr Dental AG · NBL Light-Induced Fluorescence Caries Detector
Cleared on Jan 27, 2016 as substantially equivalent to K090169 (Air Techniques, Inc., 2009) after a 317-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.
- Decided
- Jan 27, 2016
- Review
- 317 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN990002 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backDEN990002 Kavo DiagnodentKavo America · 2000
- 2 generations backK040063 Inspektor ProInspektor Dental Care BV · 2004
- 1 generation backK090169 Spectra Fluorescence Caries Detection DeviceAir Techniques, Inc. · 2009
- This deviceK150672 VistaCam iX ProofDurr Dental AG · 2016
- Descendant · cites it directly · 1 of its ownK221249 L1P-1F (Trios 5)3Shape TRIOS A/S · 2022
- Descendant · cites it directly · 1 of its ownK171007 Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK252464 Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK242103 TRIOS Ready Tip3Shape TRIOS A/S · 2025
- Descendant · cites it directly · 0 of its ownK183471 IC-WHCD100 (Inspire)Good Doctors Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K221249L1P-1F (Trios 5)3Shape TRIOS A/S · 2022 · cites it directly1descendant
- K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd. · 2018 · cites it directly1descendant
- K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K242103TRIOS Ready Tip3Shape TRIOS A/S · 2025 · 2 generations on0descendants
- K183471IC-WHCD100 (Inspire)Good Doctors Co., Ltd. · 2020 · 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 | K090169 | Spectra Fluorescence Caries Detection Device | Air Techniques, Inc. | 2009 | — |
| 0 (this device) | K150672 | VistaCam iX Proof | Durr Dental AG | 2016 | — |
| +1 | K221249 | L1P-1F (Trios 5) | 3Shape TRIOS A/S | 2022 | — |
| +1 | K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 2018 | — |
| +2 | K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | 2026 | — |
| +2 | K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 2025 | — |
| +1 | K183471 | IC-WHCD100 (Inspire) | Good Doctors Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K090169 | Spectra Fluorescence Caries Detection DeviceSummary page 5…___________________________________________________ 4. Predicate Device: Spectra Fluorescence Caries Detection Aid Device by Air Techniques, Inc. 510K# K090169 5. Device Description: The VistaCam iX “Proof” aids in the detection and diagnosis of caries. It consists of a… | 2009 |
What descends from it? (5)
3 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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221249 (3Shape TRIOS A/S, 2022) has gone furthest, with 1 descendant of its own.
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. 2016, 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 VistaCam iX "Proof" is intended to be used as an aid in the detection and diagnosis 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/K150672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150672: VistaCam iX Proof.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150672
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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