公司簡介
![proimages/about/Henry2.jpg proimages/about/Henry2.jpg](https://www.denracle.com/proimages/about/Henry2.jpg)
Milestones
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set up 2DLM team(2D:Dentist+Ph.D., L:Dental Lab, M:Manufacture)
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2DLM attends “Dental Implant Training Program” at Metal Industries Research&Development
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Green DenTech Co., Ltd(Denracle) was established
ISO 13485
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Received TFDA Class II for Implant products
GMP : Class II Dental Abutmen
TFDA : Class II The Medical Device Certificate for Dental Abutment
TFDA : Class II Endosseous Dental Implant Accessories(Non-Sterile)
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Received ISO 13485
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Received CE Calss II & CFDA Class I certifiacates Denracle Library Integrated in Exocad
CE : Class II Non-Sterile Dental Abutment
CFDA : Class I Endosseous Dental Implant Accessories
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Resceived U.S FDA Class I ceretificates Denracle Library Integrated in 3shape
U.S FDA : Class I Endosseous Dental Implant Accessories(Analog)
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Received U.S FDA Class II submission letter for Osstem system
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Launch of Denralce intra-oral scan bodies
U.S FDA : Class II Endosseous Dental Abutment
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Launch of Denracle Digital analog
Preparing U.S. FDA : Class II Endosseous Dental Abutment Accessories
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Denracle pre-milled Abutment Integrated with VHF
Certificates
![proimages/about/18569cf49fdddedaab8b728bfcc4b6210_.jpg proimages/about/18569cf49fdddedaab8b728bfcc4b6210_.jpg](https://www.denracle.com/proimages/about/18569cf49fdddedaab8b728bfcc4b6210_.jpg)
![proimages/20240624/ISO_13485_.jpg proimages/20240624/ISO_13485_.jpg](https://www.denracle.com/proimages/20240624/ISO_13485_.jpg)