FDAAugust 26, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

osstem implantosstem

UPCs

0880000099579308800000995526

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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