# K183475: T1-CS, T1-C

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Aug 30, 2019 after 256 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
Longest line of descent: 8 generations back to K973642 (1997). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart, VATECH Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K212303: T2 (2021), 1 descendant of its own
- K233806: T2 Plus (2024), 0 descendants of its own

## Recalls of this device
- Aug 26, 2025 · Class II · Z-0313-2026: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR 

## Indications for use
T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crosssectional images of the oral anatomy on a real time basis by computer reconstruction of X-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360 ° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and X-ray technicians.

Source page: https://510kreport.com/device/K183475
Methodology: https://510kreport.com/methodology