Recall Z-0313-2026— OSSTEM Implant Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by OSSTEM Implant Co., Ltd., initiated 2025-08-26. It names one FDA 510(k) clearance: K183475. Product: Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.. 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..
- Recalling firm
- OSSTEM Implant Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-26
- Firm location
- Haeundae District, N/A, Korea (the Republic of)
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.