OSSTEM Implant Co., Ltd. recalls Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

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.

Osstem Implant issued notification to customers, titled "URGENT: MEDICAL DEVICE CORRECTION", dated 08/26/2025, provided reason for recall, product description with UDI codes, corrective action, product disposition and contact information.

• FDA enforcement recordOfficial FDA database entry for Z-0313-2026
• FDA 510(k) clearance · K183475The device's official FDA premarket clearance record
• FDA device classification · OASOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find OSSTEM Implant Co., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.