Captive with pink castle in the background and image of preMill abutment showing FDA/MDR conformity seal

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 a tested and validated legal certainty workflow with FDA-cleared preMill blanks for 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.

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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 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.

CORiTEC preMill production system consisting of: CORiTEC one preMill or CORiTEC 150i PRO preMill, iCAM HD, preMill system (6-fold holder or 1-fold holder), starter kit case, tools, seal: FDA/MDR compliant

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.

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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 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.

ORDER COMPATIBILITY PLATFORM

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CORiTEC preMill system milling process with 6-fold preMill holder and seal: FDA/MDR compliant

Additional Highlights of CORiTEC preMill Manufacturing Systems

Minimize Liability Risks – Thanks to Fully Validated Processes

With the CORiTEC preMill system packages, you get a seamless and secure workflow, investing in the future of your dental practice or lab. Step into a new dimension of CORiTEC preMill abutment manufacturing with validated processes for the safety of your customers or patients.

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

INQUIRE NOW!