Astra Tech Implants - Dental System ÇƒÚCeramic AbutmentÇƒÙ

Astra Tech Implants - Dental System ÇƒÚCeramic AbutmentÇƒÙ
Summary Only:
Sponsor Name
Astra Tech, INC.
430 Bedford St, Suite 100
Lexington, MA 02240
Device Name
Proprietary Name: Astra Tech Implants - Dental System ÇƒÚCeramic AbutmentÇƒÙ
Common Name: Dental Implant
Classification name: Endosseous Dental Implant (21 CFR 872.3640)
Identification of Legally Marketed Device
o Astra Tech Implants - Dental System ÇƒÚPrepable Abutment SystemÇƒÙ
K974738
o Nobel BioCare Ceradapt K number unknown
o 3i ZiReal Post K99 1 947
Device Description
This 51Ok describes an additional component for the Astra Tech Implants - Dental System, the Ceramic Abutment.
Ceramic Abutment 45/50 ST 0 5.5 mm
The Ceramic Abutment is a transmucosal element that can be customized to meet high anatomical and esthetic demands. The Ceramic Abutment is designed to allow for individual solutions regarding function and esthetics. It is intended for cement-retained constructions and follows the same preparation
principles as for regular crown and bridgework. The cement-retained superstructure excludes the need for non-esthetic screw entries through the crown. The design provides flexibility to mimic the anatomy of a natural tooth and to compensate for non-parallel fixtures. The esthetic properties of the Ceramic Abutment create a natural appearance of the soft tissue margin as well as a better result for the all-ceramic crown restoration. The Ceramic Abutment is ground and customized to its ideal shape using diamond wheels/burrs or silicone carbide stones. The Ceramic Abutment has a conical relation to the fixture which enables a tight and stable connection between the components. There is a hexagonal interlock in relation to the fixture for antirotation and indexing. The Ceramic Abutment is connected to the fixture and tightened with the Abutment Screw ST/Long using a Hex screwdriver or Hex CA Driver.
Intended Use
The Ceramic Abutment is used with dental implant supported restorations in the anterior, canine, and premolar regions where high esthetic demands are expressed.