# K991098: Difoti System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Optical Sciences, Inc.
- Decided: Jun 30, 1999 after 90 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933455 (1994). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 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.
- (no number) Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems - preamendment, various manufacturers: named in the summary without a submission number

## Most influential descendants
- K043068: Difoti Usb 2.0 System (2004), 8 descendants of its own
- 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

## Indications for use
The DIFOTI System for Dental Examinations 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/K991098
Methodology: https://510kreport.com/methodology