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

D

DrG

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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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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.
 
OP
D

DrG

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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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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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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.
 
T

Tim Torbenson

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Hello Keith, do your "DESS Authorized" milling centers have a Quality System implemented?
 
Affinity

Affinity

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From what I understand Drs dont need FDA clearance to mill their own abutments. I could be wrong.
 
keith goldstein

keith goldstein

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From what I understand Drs dont need FDA clearance to mill their own abutments. I could be wrong.
That is incorrect. All parts that are placed in a patients mouth for more than 30 minutes needs FDA approval. So all ti bases, all stock and/or custom abutments. Also the screws that are used need to be part of the FDA submission as well. Every dentist and lab should be doing their own due diligence to ensure they are using FDA approved parts since most vendors do not speak truthfully about this.
 
2thm8kr

2thm8kr

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That is incorrect. All parts that are placed in a patients mouth for more than 30 minutes needs FDA approval. So all ti bases, all stock and/or custom abutments. Also the screws that are used need to be part of the FDA submission as well. Every dentist and lab should be doing their own due diligence to ensure they are using FDA approved parts since most vendors do not speak truthfully about this.
When did this change?
 
Affinity

Affinity

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I thought I read in a previous post on this topic that the FDA clearance was intended for the manufacturer but the dentist being the end user didnt need the FDA clearance to mill the interface. Not there are too many Drs that mill their own, maybe prosthos..
 
T

Tim Torbenson

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The FDA does not regulate the practice of medicine or dentistry. Pretty much free to do as they can but carry the legal responsibility.
 
CoolHandLuke

CoolHandLuke

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every implantable device requires certification. the attachments to that implant are considered part of the implant so titanium bases and custom abutments need to be 510k cleared. to obtain that clearance your titanium base or abutment has to be proven to be substantially similar to the original manufacturer's specifications but not so similar that in making this item you infringe on patent or trademark.

dicey game to play.

but you are correct, the fda doesn't have its own enforcement police out there like the epa.

the onus is actually on the patient to report problems.

ref:
 
Sda36

Sda36

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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.
Mark Jackson lis still with us ❤
 
keith goldstein

keith goldstein

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When did this change?
This never changed. It does not matter if you are a dentist or a dental lab using a stock abutment or making any custom abutment the same rules have always applied (since the FDA began requiring that all implant abutments are FDA registered 25+ years ago) the part (implant connection and screw) have to be FDA registered/approved. The dentist do not have any special rights. It raises a number of concerns when a part is not approved since it means there is no testing done on it's long term fit and tolerance of the connection and the screw.
 
CoolHandLuke

CoolHandLuke

40% titanium
Staff member
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This never changed. It does not matter if you are a dentist or a dental lab using a stock abutment or making any custom abutment the same rules have always applied (since the FDA began requiring that all implant abutments are FDA registered 25+ years ago) the part (implant connection and screw) have to be FDA registered/approved. The dentist do not have any special rights. It raises a number of concerns when a part is not approved since it means there is no testing done on it's long term fit and tolerance of the connection and the screw.
and just to add to that there is a difference between FDA Cleared and FDA Approved. Cleared devices are largely similar to historic devices, but Approved devices have been time tested in the patient in clinical trials (which are overseen by basically the company pushing the device, which creates its own special problem of truthfulness and honesty)
 
T

Tim Torbenson

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Mark Jackson lis still with us ❤
The pathway to FDA compliance for a CAD/CAM dental lab is no where near that intrusive. It sounds like you have described DAMAS which is not a regulatory requirement for any lab, DAMAS is overly complicated and has outlived its practicality and usefulness. The real FDA requirements are less than the overly burdensome DAMAS scheme requirements.
 
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OP
D

DrG

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I would add, as the title of the thread suggest that the FDA clearance for a custom abutment milled needs to involve:
-The blank
-The CAD software
-The CAM software
Whether you like Straumann or not, they provide a full FDA cleared flow to mill in-house a custom abutment. It involves using their CARES cadcam solution and their M series mill.
Are there any other systems that allow for an FDA cleared solution ? I don't know

For ex: AG ceramill and their exo CADCAM: Do they have a workflow that is FDA cleared ?, what blank and CADCAM software?
Same for Versamill and others : what blank and CADCAM software ?
Please educate me and let's populate the list.
 
T

Tim Torbenson

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That is inaccurate. The FDA requirements are on the CAD and the milled components, not on the CAM or the mill. There is so much misinformation out there to scare you into buying overpriced systems like the Straumann or Sirona. The open systems are more affordable and easier to maintain. Most will also offer greater variety and options with your source for Ti bases or Ti blanks.

You can get any mix of CAD, CAM and equipment to mill the many options of 510(k) cleared Ti components. You will need to implement a Quality System and document some procedures to validate the process to satisfy the FDA. This is what we do, help labs to enter into these manufacturing processes and be compliant with the FDA. Our clients that were FDA audited, have experienced no problems with the FDA.

The FDA requirements are straightforward and not difficult to manage in any sized lab. There is just too many companies doing a good job of scaring lab owners. Shoot me a message and I will be happy to share the reality of the FDA requirements.
 
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