What certifications and registrations has DESS obtained?
- 2000 - ISO 9001 Certification
- 2008 - Sanitary certificate ISO 13485 and CE
- 2015- Health Canada approval
- All our titanium is ASTM-F136 certified from European supplier
How does DESS create cross compatible components?
The abutment and screw connection involves creating highly accurate geometry and extremely precision machining. We utilize the same technology as the major implant companies including the same design programs, same Swiss & Japanese machines, and same metrology measurement instruments. DESS even manufactures for some of the implant companies. Regarding patents most connection methods are not patented.
In order to manufacture a compatible component the original implants must be utilized (typically a minimum of 20 of each platform). We measure original components to get a CAD image, produce prototypes and test – both mechanically and with sophisticated measuring instruments (metrology systems) and based on these thorough evaluations we set our own tolerances to assure fit and compatibility all the time. Extensive stress testing on the components are performed.
What regulatory agencies ensure cross compatibility?
Not all medical authorities require proof of fit. Canada Health and FDA does and in obtaining their certification, DESS proved that we produce components that systematically fits original implant systems.
Therefore if a manufacturer has CE Approval, ISO 9000, or ISO 13485 they do not have any proof of fit and therefore you are NOT ensured that the components are cross compatible.
DESS has Health Canada approval and is pending FDA.
What Quality Assurance does DESS provide?
All of our parts are within a 10 to 20 micron accuracy.
Every batch of components goes through a series of measurement and quality control inspections to ensure that the geometry, tolerance, and fit of the manufactured part matches the original CAD dimensions. This is done using two types of measurement/metrology systems (Reinshaw touch probe and optical/vision system). The part is measured in multiple locations and every section has to pass in order to be acceptable to move onto visual inspections.
Each component is then inspected visually following the ISO rules to assure quality.
Since 2008 we have a sanitary department with our own clean room and backed by our CE and ISO 13485 certification. Our entire manufacturing process is regulated under the EU Medical Directive 93/42/CEE (as amended by Directive 2007/47/CE). The process follows ISO 9001:2008 & ISO 13485:2012 and it is yearly audited by the Notified Body.
All our titanium is ASTM-F136 certified from European supplier.
DESS has both CE and Health Canada approval
What is Select Grip Surface and what are the benefits?
SELECT GRIP® is a special sandblasted surface applied to the following titanium abutments - ti bases, straight, angled, titanium temporary and to our chrome cobalt bases. As compared to a stock titanium abutment with no surface treatment the DESS titanium abutment with the SelectGrip surface provide 5 times greater adhesion between the abutment and the crown.
The DESS Ti Bases/Verification jigs with the SelectGrip surface provides provide 2.5 times greater adhesion between the abutment and the crown versus ti bases with no surface treatment.
This saves labs and dentist time having to sandblast or roughen the surface on the abutment too.