510(k) · Cleared
ClearediTero Element 5D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Align Technology, Inc. · NTK Light Transmission Caries Detector
Cleared on Mar 20, 2020 as substantially equivalent to K172007 (Duerr Dental AG, 2017) after an 81-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 20, 2020
- Review
- 81 days
- Class
- Class II
- Product code
- NTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933455 (1994). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 4 generations backK991098 Difoti SystemElectro-Optical Sciences, Inc. · 1999
- 3 generations backK043068 Difoti Usb 2.0 SystemElectro-Optical Sciences, Inc. · 2004
- 2 generations backK123402 DiagnocamKaltenbach & Voigt GmbH · 2013
- 1 generation backK172007 CamX Triton HD Proxi HeadDuerr Dental AG · 2017
- This deviceK193659 iTero Element 5DAlign Technology, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK240573 iTero Lumina™ ProAlign Technology, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK261847 iTero Lumina™ ProAlign Technology, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −4 | K991098 | Difoti System | Electro-Optical Sciences, Inc. | 1999 | — |
| −3 | K043068 | Difoti Usb 2.0 System | Electro-Optical Sciences, Inc. | 2004 | — |
| −2 | K123402 | Diagnocam | Kaltenbach & Voigt GmbH | 2013 | — |
| −1 | K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | 2017 | — |
| 0 (this device) | K193659 | iTero Element 5D | Align Technology, Inc. | 2020 | — |
| +1 | K240573 | iTero Lumina™ Pro | Align Technology, Ltd. | 2024 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 K261847 iTero Lumina™ Proscore 13.4 · 7 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 |
|---|---|---|---|
| * | K172007 | CamX Triton HD Proxi HeadSummary page 4…r fluorescence caries detection device Regulatory Class: Class II Product Code: NTK Regulation Number: 21 CFR 872.1745 Predicate Devices: CamX Triton HD Proxi Head (K172007) Device Description The iTero Element 5D is an integrated intraoral imaging system capable of 3D confocal optical impressions f… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240573 | iTero Lumina™ Pro | 2024 | 1 |
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 26 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K240573 (Align Technology, Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K172007.
How does its category compare?
All NTK devicesNTK Light Transmission Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Element 5D is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193659: iTero Element 5D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193659
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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