Can you already hear the handcuffs clicking?
As the pioneering manufacturer worldwide, imes-icore brings you validated legal certainty with FDA-cleared and tested workflows for crafting custom abutments. You're ensuring compliance with regulatory mandates, meeting the highest standards of safety and efficiency, and minimizing liability risks for dental practices and labs.
FDA classifies customized abutment milling as the production of a Class II medical device. For legal security, labs milling custom implant abutments with CAD/CAM technology must claim a validated milling center, including a detailed setup and equipment listing, and implement a quality management system. Alternatively, they must obtain a 510(k) clearance and registration with a legalized digital workflow before commencing production.
To offer your customers the ideal solution for minimizing liability risks, imes-icore has tailored the perfect solution for you: The CORiTEC preMill Manufacturing System, comprising CORiTEC preMill abutment, holder system, modified CAM, and CORiTEC preMill milling machine.
CORiTEC one preMill and CORiTEC 150i PRO preMill both offer:
|CORiTEC one preMill||CORiTEC 150i PRO preMill|
|Integrated Control PC||✔||✔|
|Enclosed monoblock casting body for stability and precision||✔||✔|
|High precision through integrated temperature compensation||✔||✔|
|Short amortization period||✔||✔|
|Integrated single block holder for CORiTEC preMill abutments||✔||✖|
|Integrated 6-fold holder for CORiTEC preMill abutments||✖||✔|
|Metal processing of blanks||✖||✔|
With the CORiTEC preMill system packages, your customers get a seamless and secure workflow, investing in the future of their dental practice or lab. Step into a new dimension of CORiTEC preMill abutment manufacturing with validated processes for the safety of your customers and their patients.
Don't waste another momentput an end to your worries about liability risks now!