510(k) · Cleared
ClearedDifoti System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro-Optical Sciences, Inc. · EIA Unit, Operative Dental
Cleared on Jun 30, 1999 as substantially equivalent to K933455 (Schick Technologies, Inc., 1994) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1994. 10 later devices descend from it.
- Decided
- Jun 30, 1999
- Review
- 90 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933455 (1994). 2 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- This deviceK991098 Difoti SystemElectro-Optical Sciences, Inc. · 1999
- Descendant · cites it directly · 8 of its ownK043068 Difoti Usb 2.0 SystemElectro-Optical Sciences, Inc. · 2004
- Descendant · 2 generations on · 7 of its ownK123402 DiagnocamKaltenbach & Voigt GmbH · 2013
- Descendant · 2 generations on · 4 of its ownK172007 CamX Triton HD Proxi HeadDuerr Dental AG · 2017
- Descendant · 3 generations on · 2 of its ownK193659 iTero Element 5DAlign Technology, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK240573 iTero Lumina™ ProAlign Technology, Ltd. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K043068Difoti Usb 2.0 SystemElectro-Optical Sciences, Inc. · 2004 · cites it directly8descendants
- K123402DiagnocamKaltenbach & Voigt GmbH · 2013 · 2 generations on7descendants
- K172007CamX Triton HD Proxi HeadDuerr Dental AG · 2017 · 2 generations on4descendants
- K193659iTero Element 5DAlign Technology, Inc. · 2020 · 3 generations on2descendants
- K240573iTero Lumina™ ProAlign Technology, Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| 0 (this device) | K991098 | Difoti System | Electro-Optical Sciences, Inc. | 1999 | — |
| +1 | K043068 | Difoti Usb 2.0 System | Electro-Optical Sciences, Inc. | 2004 | — |
| +2 | K123402 | Diagnocam | Kaltenbach & Voigt GmbH | 2013 | — |
| +2 | K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | 2017 | — |
| +3 | K193659 | iTero Element 5D | Align Technology, Inc. | 2020 | — |
| +4 | K240573 | iTero Lumina™ Pro | Align Technology, Ltd. | 2024 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…640). Predicate Devices: Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems - preamendment, various manufacturers Computer Oral Radiography System (K933455) and CDR-CAM (K 963778) Schick Technologies, Inc. Product Description: The DIFOTI device is a dental examination system that ut… | 1994 |
| * | K963778 | CDR-CamSummary page 1…es: Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems - preamendment, various manufacturers Computer Oral Radiography System (K933455) and CDR-CAM (K 963778) Schick Technologies, Inc. Product Description: The DIFOTI device is a dental examination system that utilizes visible light de… | 1996 |
| * | — | Fiberoptic transillumination (FOTI) fiberoptic dental imaging systems - preamendment… Named without a submission number |
What descends from it? (10)
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?
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991098: Difoti System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991098
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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