510(k) · Cleared
ClearedDifoti Usb 2.0 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro-Optical Sciences, Inc. · NTK Light Transmission Caries Detector
Cleared on Dec 29, 2004 as substantially equivalent to K933455 (Schick Technologies, Inc., 1994) and 2 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1994. 8 later devices descend from it.
- Decided
- Dec 29, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- NTK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933455 (1994). 3 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 1 generation backK991098 Difoti SystemElectro-Optical Sciences, Inc. · 1999
- This deviceK043068 Difoti Usb 2.0 SystemElectro-Optical Sciences, Inc. · 2004
- 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 |
|---|---|---|---|---|---|
| −2 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −1 | K991098 | Difoti System | Electro-Optical Sciences, Inc. | 1999 | — |
| 0 (this device) | K043068 | Difoti Usb 2.0 System | Electro-Optical Sciences, Inc. | 2004 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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? (4)
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 |
|---|---|---|---|
| * | K933455 | Computed Oral Radiology SystemSummary page 1…eroptic dental imaging systems- preamendment, various manufacturers Computer Oral Radiography System (K933455) and CDR-CAM (K963778) Schick Technologies, Inc. DIFOTI System for… | 1994 |
| * | K963778 | CDR-CamSummary page 1…ging systems- preamendment, various manufacturers Computer Oral Radiography System (K933455) and CDR-CAM (K963778) Schick Technologies, Inc. DIFOTI System for Dental Examinations (K… | 1996 |
| * | K991098 | Difoti SystemSummary page 1…phy System (K933455) and CDR-CAM (K963778) Schick Technologies, Inc. DIFOTI System for Dental Examinations (K99 1098), Electro-Optical Sciences, Inc. Product Description: The device known as the DIFOTI USB 2.0 Syst… | 1999 |
| * | — | Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems — preamendment… 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123402 (Kaltenbach & Voigt GmbH, 2013) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K933455.
How does its category compare?
All NTK devicesNTK Light Transmission Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DIFOTI USB 2.0 System is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043068: Difoti Usb 2.0 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043068
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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