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

Medical DevicesSource: FDA (device) · Date: 2025-11-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
OSSTEM Implant Co., Ltd.
Product
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S.
Recall initiated
2025-08-26
Code info
UDI Codes: 08800000995793 and 08800000995526.
Product quantity
N/A
Voluntary mandated
FDA Mandated
City
Haeundae District
State
N/A
Country
Korea (the Republic of)
Event id
97869
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