# K963778: CDR-Cam

- Pathway: 510(k) (Traditional)
- Applicant: Schick Technologies, Inc.
- Decided: Nov 22, 1996 after 63 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
No predicates in its family tree.
14 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K991098: Difoti System (1999), 10 descendants of its own
- 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

Source page: https://510kreport.com/device/K963778
Methodology: https://510kreport.com/methodology