# K043068: Difoti Usb 2.0 System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Optical Sciences, Inc.
- Decided: Dec 29, 2004 after 51 days
- Product code: NTK (Light Transmission Caries Detector)
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933455 (1994). 3 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933455: Computed Oral Radiology System, Schick Technologies, Inc. (1994) Summary page 1.
- K963778: CDR-Cam, Schick Technologies, Inc. (1996) Summary page 1.
- K991098: Difoti System, Electro-Optical Sciences, Inc. (1999) Summary page 1.
- (no number) Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems — preamendment, various manufacturers: named in the summary without a submission number

## Most influential descendants
- K123402: Diagnocam (2013), 7 descendants of its own
- K172007: CamX Triton HD Proxi Head (2017), 4 descendants of its own
- K193659: iTero Element 5D (2020), 2 descendants of its own
- K240573: iTero Lumina™ Pro (2024), 1 descendant of its own
- K182712: DEXIS CariVu 3-in-1 by KaVo (2019), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K043068
Methodology: https://510kreport.com/methodology