# K133406: CS 8100 3D

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Mar 14, 2014 after 128 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (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 8, 2015 · Class II · Z-1378-2015: Units device head descended unexpectedly

## Indications for use
The CS 8100 3D is intended to produce complete or segmented tomographic digital panoramic images and three-dimensional digital X-ray images of the dento-maxillofacial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. In addition, the CS 8100 3D is provided with a radiological exam option which allows the display of one determined third molar segment of the dental structures using the capability of the system to explore each slice acquired during an exam.

Source page: https://510kreport.com/device/K133406
Methodology: https://510kreport.com/methodology