# K233806: T2 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Sep 6, 2024 after 282 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: 10 generations back to K973642 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212303: T2, Osstem Implant Co., Ltd. (2021) Summary page 5.

## Recalls of this device
- Aug 26, 2025 · Class II · Z-0315-2026: 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
T2 PLUS is digital X-Ray imaging equipment for dental professionals that converts X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (PANO), Cephalometric (CEPH), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area. T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians. Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.

Source page: https://510kreport.com/device/K233806
Methodology: https://510kreport.com/methodology