510(k) · Cleared
ClearediTero Lumina™ Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Align Technology, Ltd. · NTK Light Transmission Caries Detector
Cleared on Jul 2, 2026 as substantially equivalent to K240573 (Align Technology, Ltd., 2024) after a 29-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jul 2, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- NTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K933455 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 6 generations backK991098 Difoti SystemElectro-Optical Sciences, Inc. · 1999
- 5 generations backK043068 Difoti Usb 2.0 SystemElectro-Optical Sciences, Inc. · 2004
- 4 generations backK123402 DiagnocamKaltenbach & Voigt GmbH · 2013
- 3 generations backK172007 CamX Triton HD Proxi HeadDuerr Dental AG · 2017
- 2 generations backK193659 iTero Element 5DAlign Technology, Inc. · 2020
- 1 generation backK240573 iTero Lumina™ ProAlign Technology, Ltd. · 2024
- This deviceK261847 iTero Lumina™ ProAlign Technology, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −6 | K991098 | Difoti System | Electro-Optical Sciences, Inc. | 1999 | — |
| −5 | K043068 | Difoti Usb 2.0 System | Electro-Optical Sciences, Inc. | 2004 | — |
| −4 | K123402 | Diagnocam | Kaltenbach & Voigt GmbH | 2013 | — |
| −3 | K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | 2017 | — |
| −2 | K193659 | iTero Element 5D | Align Technology, Inc. | 2020 | — |
| −1 | K240573 | iTero Lumina™ Pro | Align Technology, Ltd. | 2024 | — |
| 0 (this device) | K261847 | iTero Lumina™ Pro | Align Technology, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2007 | 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 NTK? 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 NTK device
- #1 K240573 iTero Lumina™ Proscore 12.4 · 6 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 |
|---|---|---|---|
| * | K240573 | iTero Lumina™ ProSummary page 5…ication Name: Laser fluorescence caries detection device Regulation Number and Class: 21 CFR 872.1745, Class II Product Code: NTK Predicate Device: iTero Lumina Pro™ (K240573), Align Technology Ltd. Device Description The modified iTero Lumina Pro is an integrated intraoral imaging system capable of c… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 6 companies; a new generation was cleared every 4.4 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All NTK devicesNTK Light Transmission Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NTK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NTK
Too few NTK 510(k)s in any year since 2007 to give a median.
Recalls per year · NTK
No recall names NTK since 2007.
Adverse event reports per year · NTK
2in 2025
MAUDE reports naming product code NTK, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The iTero Lumina Pro NIRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.
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/K261847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261847: iTero Lumina™ Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261847
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026