# K060292: Kodak Models 2100 and 2200

- Pathway: 510(k) (Special)
- Applicant: Kodak-Trophy
- Decided: Mar 3, 2006 after 25 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 24, 2014 · Class II · Z-1127-2014: Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.
- Jan 24, 2014 · Class II · Z-1128-2014: Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage.

## Indications for use
Kodak 2100 and Kodak 2200, intra-oral X-ray generators are intended for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.

Source page: https://510kreport.com/device/K060292
Methodology: https://510kreport.com/methodology