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Better safe than sorry: FDA-cleared preMill Manufacturing Systems!

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.

Legal Context in a Nutshell

In the US, the FDA classifies customer-specific milling as the manufacture of a Class II medical device. Labs milling custom implant abutments with CAD/CAM technology must either commission a validated milling center (VMS) with a listing of the facility and devices, and implement a Quality Management System or use products with a 510(k) pre-market clearance and registration with a validated digital workflow.

Don't waste another moment – put an end to your worries about liability risks now!

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:

  • FDA-510(k) clearence components and strategies for in-house milling
  • Coordinated system package for preMill abutments
  • Compatibility with major implant platforms and all implant indications
  • Free CAM software
  • Fast and reliable results through reproducible processes
  • Integrated HD camera for machine room monitoring
  • Wet and dry processing

 

All CORiTEC blanks, which are available in all implant systems, are supplied without exception including the corresponding abutment screw. When ordering the complete CORiTEC 150i PRO preMill or CORiTEC one preMill system, six blanks of your choice are included in the delivery. The range of CORiTEC preMill blanks is continuously being expanded with compatible platforms for implant systems.

Additional Highlights of CORiTEC preMill Manufacturing Systems

 CORiTEC one preMillCORiTEC 150i PRO preMill
Integrated Control PC
Auto-calibration
Enclosed monoblock casting body for stability and precision
High precision through integrated temperature compensation
Minimal footprint
Short amortization period
Integrated single block holder for CORiTEC preMill abutments
Integrated 6-fold holder for CORiTEC preMill abutments
C-Clamp holder*
Metal processing of blanks

Minimize Liability Risks – Thanks to Fully Validated Processes

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 moment
put an end to your worries about liability risks now!