Osstem Dental X-Ray System (Osstem) – Labeling Issue (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Brand
OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)
Lot Codes / Batch Numbers
UDI Codes: 08800000995793 and 08800000995526.
Products Sold
UDI Codes: 08800000995793 and 08800000995526.
OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of) is recalling Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. due to Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missin. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026