List of FDA approved custom milled ti abutment blank/mill combo

D

DrG

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#1
What custom abut can be milled in-house and be FDA approved ?
1-Straumann RC or NC connection on AG mill or Straumann M series mill
What else ?
 
Jason D

Jason D

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#3
First off you need to understand fda terminology.
“Fda approved” relates to drugs and class 3 items.
Therefore the fda does not “approve” dental restorative devices (abutments)

The fda “clears” things like abutment platform and connections as being substantially similar to other devices and meeting the descriptions of design provided. The fda does NOT evaluate the effectiveness of those materials and processes, simply that the documentation reflects the product or process accurately.

(Effectiveness testing as in the pharmaceutical industry include clinical trials etc. a new abutment platform is not subjected to such conditions.)

An enterprise must be “FDA Compliant” to produce abutments, using 510k cleared materials.
The compliance and documentation and materials tracking required are covered in cfr 820.
 
D

DrG

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#4
First off you need to understand fda terminology.
“Fda approved” relates to drugs and class 3 items.
Therefore the fda does not “approve” dental restorative devices (abutments)

The fda “clears” things like abutment platform and connections as being substantially similar to other devices and meeting the descriptions of design provided. The fda does NOT evaluate the effectiveness of those materials and processes, simply that the documentation reflects the product or process accurately.

(Effectiveness testing as in the pharmaceutical industry include clinical trials etc. a new abutment platform is not subjected to such conditions.)

An enterprise must be “FDA Compliant” to produce abutments, using 510k cleared materials.
The compliance and documentation and materials tracking required are covered in cfr 820.
Thank you Jason for the above information.
If a Ti blank is to be milled into a Ti abutment, the blank needs to be 510k cleared, I get it. Does FDA has any red tape/regulation on the millling machine and CAD/CAM software to produce a product that is safe and at least as good as the standard equivalent it is being compared to ?
I suppose the answer to my question lies in that the enterprise must be FDA compliant and documents it with cfr820, correct ?
 
Jason D

Jason D

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#5
Thank you Jason for the above information.
If a Ti blank is to be milled into a Ti abutment, the blank needs to be 510k cleared, I get it. Does FDA has any red tape/regulation on the millling machine and CAD/CAM software to produce a product that is safe and at least as good as the standard equivalent it is being compared to ?
I suppose the answer to my question lies in that the enterprise must be FDA compliant and documents it with cfr820, correct ?
That is correct, there is a fairly exhaustive process to achieve compliance, including simple things like lot tracking and more complex items ranging from failure root cause analysis and tracking, and equipment maintenance/calibration logs and ability to track every component from supplier through manufacturing process including which mill is used and the tool records and Ac process with designated responsible individuals and the standards they certify it meets.

Basically a client can be provided the tracking of every step of the manufacture, of every component that went into a case, and the validations that every piece of equipment was used properly and that the results met a verifiable standard which was examined and documented by a Qc tech who was authorized to make such determinations.
 
DESS-USA

DESS-USA

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#6
Jason thanks for clarifying this. DESS makes 510K cleared premilled blanks that can milled on numerous milling machines (Versamill, imes, vhf, zz, etc) and we have a standard agreement to authorize the user to be a "DESS Authorized" milling center.
 
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