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Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

FDA Recall #Z-0313-2026 — Class II — August 26, 2025

Recall #Z-0313-2026 Date: August 26, 2025 Classification: Class II Status: Ongoing

Product Description

Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

Reason for Recall

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.

Recalling Firm

OSSTEM Implant Co., Ltd. — Haeundae District, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

U.S.

Code Information

UDI Codes: 08800000995793 and 08800000995526.

Status

Ongoing

Voluntary / Mandated

FDA Mandated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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