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Sources: EU EUDAMED, US FDA
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Country: France
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Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.
FDA Enforcement
Class II
·Terminated·Anthogyr·September 14, 2016
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
FDA Enforcement
Class II
·Ongoing·Clariance-SAS·April 22, 2026
Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.
FDA Enforcement
Class II
·Terminated·Anthogyr·September 14, 2016
FDI FRANCE
Manufacturer
🇫🇷 France·3 Basic UDI-DIs·125 Devices
Artis CF
Manufacturer
🇫🇷 France·1 Basic UDI-DI·1 Device
ACCESS COMFORT GREY
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT BLACK
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT PURPLE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT BEIGE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT BLUE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT RED
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT WHITE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT GREY
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT PURPLE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT BEIGE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ACCESS COMFORT BLACK
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
PREMIUM RED
Device
EU MDR
·
Eu Md Class 1
·FDI FRANCE·On the market
PREMIUM WHITE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
PREMIUM PURPLE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market
ERGOTECH BEIGE
Device
EU MDR
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Eu Md Class 1
·FDI FRANCE·On the market