510(k) · Cleared
ClearedDiagnocam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaltenbach & Voigt GmbH · NTK Light Transmission Caries Detector
Cleared on Sep 24, 2013 as substantially equivalent to K043068 (Electro-Optical Sciences, Inc., 2004) and 1 other predicate after a 323-day review. Its family tree reaches back 3 generations to 1994. 7 later devices descend from it.
- Decided
- Sep 24, 2013
- Review
- 323 days
- Class
- Class II
- Product code
- NTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933455 (1994). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 2 generations backK991098 Difoti SystemElectro-Optical Sciences, Inc. · 1999
- 1 generation backK043068 Difoti Usb 2.0 SystemElectro-Optical Sciences, Inc. · 2004
- This deviceK123402 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 · cites it directly · 1 of its ownK182712 DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH · 2019
- Descendant · 4 generations on · 0 of its ownK261847 iTero Lumina™ ProAlign Technology, Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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 · cites it directly1descendant
- K261847iTero Lumina™ ProAlign Technology, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −2 | K991098 | Difoti System | Electro-Optical Sciences, Inc. | 1999 | — |
| −1 | K043068 | Difoti Usb 2.0 System | Electro-Optical Sciences, Inc. | 2004 | — |
| 0 (this device) | 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 | — |
| +1 | K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | 2019 | — |
| +4 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K043068 | Difoti Usb 2.0 SystemSummary page 1…Classification Name - Laser fluorescence caries detection device, per 21 CFR §872.1745 Devices for Which Substantial Equivalence is Claimed: * DIFOTI USB 2.0 SYSTEM (K043068) * Transillumination Cable T12200 (K071429) Device Description: The VIA GNOcam 2170 is a handheld laser fluorescence caries… | 2004 |
| * | K071429 | TI2200 Transillumination CableSummary page 1…s detection device, per 21 CFR §872.1745 Devices for Which Substantial Equivalence is Claimed: * DIFOTI USB 2.0 SYSTEM (K043068) * Transillumination Cable T12200 (K071429) Device Description: The VIA GNOcam 2170 is a handheld laser fluorescence caries detection device which uses the DIFOTI technol… | 2007 |
What descends from it? (7)
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K172007 (Duerr Dental AG, 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K043068.
How does its category compare?
All NTK devicesNTK Light Transmission Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 DIAGNOcam 2170 is a diagnostic aid for the detection of open or incipient caries lesions above the gingiva and for monitoring the progress of such lesions.
Indications:
* Detection of smooth surface caries
* Detection of occlusal caries
* Detection of proximal caries
* Detection of initial caries
* Detection of secondary caries
* Detection of cracks
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123402: Diagnocam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123402
Report an extraction error
Are you the manufacturer?
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