510(k) · Cleared
ClearedCDR-Cam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schick Technologies, Inc. · EIA Unit, Operative Dental
Cleared on Nov 22, 1996 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it.
- Decided
- Nov 22, 1996
- Review
- 63 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 5 citing it directly.
- This deviceK963778 CDR-CamSchick Technologies, Inc. · 1996
- Descendant · cites it directly · 10 of its ownK991098 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K991098Difoti SystemElectro-Optical Sciences, Inc. · 1999 · cites it directly10descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963778 | CDR-Cam | Schick Technologies, Inc. | 1996 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 145 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?
- Of its descendants, K991098 (Electro-Optical Sciences, Inc., 1999) has gone furthest, with 10 descendants of its own.
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 | — |
https://510kreport.com/device/K963778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963778: CDR-Cam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963778
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026