8 results
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48ms
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Sources: EU EUDAMED, US FDA
Sinol Dental Limited
Manufacturer
🇨🇳 China
SINOL DENTAL LIMITED
FDA registration
SINOL DENTAL LIMITED·5 products·🇨🇳 China
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
FDA Enforcement
Class II
·Terminated·Nakanishi Inc.·September 7, 2016
Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
FDA Recall
Terminated
·Keystone Dental Inc·Product code DZE·May 1, 2018
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
FDA Recall
Terminated
·Nakanishi Inc. 700 Shimohinata Kanuma Japan·Product code EFB·July 8, 2016
European Healthcare & Device Solutions Ltd.
Authorized representative
🇮🇪 Ireland·66 Manufacturers·867 Devices
Prolinx GmbH
Authorized representative
🇩🇪 Germany·97 Manufacturers·1780 Devices