---
title: "Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. — FDA record Z-0315-2026 | Is It on Recall"
description: "Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a requir"
url: https://isitonrecall.com/recall/fda-device-z-0315-2026-osstem-dental-x-ray-system-t2plus-product-model-numbers-t2-c-p-and-t2-cs-p/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. — FDA record Z-0315-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
- **Reason**: 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 Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- **Classification**: Class II
- **Recalling firm**: OSSTEM Implant Co., Ltd.
- **Quantity**: N/A
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0315-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0315-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI Codes: 08800000996059 and 08800000996042. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Nov 12, 2025
- **Recall initiation date**: Aug 26, 2025
- **Center classification date**: Nov 5, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0315-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [OSSTEM Implant Co., Ltd. records](https://isitonrecall.com/brand/osstem-implant-co-ltd/)