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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Osstem Implant Co.,Ltd.
FDA UDI
Osstem Implant Co.,Ltd.·08800000995755·The BeauTis White Light is a teeth whitening la...
Osstem Implant Co.,Ltd.
FDA UDI
Osstem Implant Co.,Ltd.·08800000995649·This device is an oral camera device that can b...
Osstem Implant Co.,Ltd.
FDA UDI
Osstem Implant Co.,Ltd.·08800000995656·The intraoral camera with a B applied Part is i...
Osstem Implant Co.,Ltd.
FDA UDI
Osstem Implant Co.,Ltd.·08800000995762·The BeauTis Light S is a teeth whitening lamp t...
OSSTEM IMPLANT CO., LTD.
FDA registration
OSSTEM IMPLANT CO., LTD.·3 products·🇰🇷 South Korea
OSSTEM IMPLANT CO., LTD.
FDA registration
OSSTEM IMPLANT CO., LTD.·17 products·🇰🇷 South Korea
OSSTEM IMPLANT CO., LTD.
FDA registration
OSSTEM IMPLANT CO., LTD.·26 products·🇰🇷 South Korea
OSSTEM IMPLANT CO.,LTD.
FDA registration
OSSTEM IMPLANT CO.,LTD.·6 products·🇰🇷 South Korea
OSSTEM IMPLANT CO., LTD.
FDA registration
OSSTEM IMPLANT CO., LTD.·3 products·🇰🇷 South Korea
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA registration
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS·4 products·🇰🇷 South Korea
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA UDI
Osstem Implant Co.,Ltd.·08800000995052·A unit that provides the media necessary for no...
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA UDI
Osstem Implant Co.,Ltd.·08800000996264·The K5 is intended to supply power to and serve...
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA UDI
Osstem Implant Co.,Ltd.·08800000995830·
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA UDI
Osstem Implant Co.,Ltd.·08800000995977·The K5 is intended to supply power to and serve...
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA UDI
Osstem Implant Co.,Ltd.·08800000995984·The K5 is intended to supply power to and serve...
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA UDI
Osstem Implant Co.,Ltd.·08800000995045·A unit that provides the media necessary for no...
OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS
FDA UDI
Osstem Implant Co.,Ltd.·08800000995724·A unit that provides the media necessary for no...
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025