Can I Mill Custom Abutments?

That’s the question on everyone’s mind these days, especially since the NADL released an alert on the in-house milling of custom abutments in November. Confusion, questions and rumors abound on the issue of what laboratories can and can’t do when complying with the FDA.

The FDA classifies implant abutments as a Class II medical device and it wants to know what the supply chain looks like, who is doing what, with what tools and that the process is sound all the way through. A key concern is controlling the angulation of the abutment and ensuring a laboratory doesn’t exceed FDA-cleared design parameters when it’s using CAD/CAM technology.

The NADL’s November alert and subsequent article in the January issue of JDT—which contains information taken directly from FDA’s written communications to manufacturers, milling centers and NADL—says:

• Ti-base/hybrid abutments: You can CAD/CAM mill...
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