510(k) · Cleared
ClearedTI2200 Transillumination Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerr Corporation · NTK Light Transmission Caries Detector
Cleared on Sep 10, 2007 after a 110-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Sep 10, 2007
- Review
- 110 days
- Class
- Class II
- Product code
- NTK
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK071429 TI2200 Transillumination CableKerr Corporation · 2007
- Descendant · cites it directly · 7 of its ownK123402 DiagnocamKaltenbach & Voigt GmbH · 2013
- Descendant · cites it directly · 4 of its ownK172007 CamX Triton HD Proxi HeadDuerr Dental AG · 2017
- Descendant · 2 generations on · 2 of its ownK193659 iTero Element 5DAlign Technology, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK240573 iTero Lumina™ ProAlign Technology, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK182712 DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K123402DiagnocamKaltenbach & Voigt GmbH · 2013 · cites it directly7descendants
- K172007CamX Triton HD Proxi HeadDuerr Dental AG · 2017 · cites it directly4descendants
- K193659iTero Element 5DAlign Technology, Inc. · 2020 · 2 generations on2descendants
- K240573iTero Lumina™ ProAlign Technology, Ltd. · 2024 · 3 generations on1descendant
- K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071429 | TI2200 Transillumination Cable | Kerr Corporation | 2007 | — |
| +1 | K123402 | Diagnocam | Kaltenbach & Voigt GmbH | 2013 | — |
| +1 | K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | 2017 | — |
| +2 | K193659 | iTero Element 5D | Align Technology, Inc. | 2020 | — |
| +3 | K240573 | iTero Lumina™ Pro | Align Technology, Ltd. | 2024 | — |
| +2 | K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | — | Microlux Transilluminator Named without a submission number |
What descends from it? (8)
2 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?
- Of its descendants, K123402 (Kaltenbach & Voigt GmbH, 2013) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NTK devicesNTK Light Transmission Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Ti2200 TransilluminationCable is a diagnostic aid used to locate decay, calculus,
fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface utilizing
a fiber optic cable and handle attached to a light source.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071429: TI2200 Transillumination Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071429
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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