510(k) · Cleared
ClearedTIA Tip, Cariosity, Transillumination Accessory Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D4D Technologies, LLC · NTK Light Transmission Caries Detector
Cleared on Apr 29, 2022 as substantially equivalent to K172007 (Duerr Dental AG, 2017) after a 182-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Apr 29, 2022
- Review
- 182 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. No later device cites it as a predicate yet.
- 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 deviceK213482 TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLC · 2022
View 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) | K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies, LLC | 2022 | — |
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 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…Product Code: NTK Device Class: Class 2 Medical Specialty: Dental 5.4 Predicate Device(s) CamX Triton HD Proxi Head (K172007); Duerr Dental AG 5.5 Device Description The TIA Tip is an optional interchangeable component tip assembly that works… | 2017 |
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 28 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.
- 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. 2022, 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 TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213482: TIA Tip, Cariosity, Transillumination Accessory Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213482
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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