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

[DrG]

Thanks Tim for the clarification.
So If I understand correctly:
a)-If I have an FDA validated workflow such as Straumann CARES, I am covered because the whole workflow has been 510k cleared
b)-If I have a mix of CADCAM equipment with a non 510k cleared workflow, I need to implement the Quality System and document the procedures.

Now there is a cost and precious time associated with b): how much ?

 

[Tim Torbenson]

Hello DrG, I am going to assume you are a dentists. Please correct me if I am wrong.

If that is the case, you are not required to have a "quality system" (QS) implemented as the FDA does not regulate the medical or dental practice.

To cover your legal liabilities, I would strongly suggest a QS lite that will document and guide you and your team on the required maintenance on the equipment to assure quality production of the restorations/devices. These tasks will be done and the QS will document the tasks to validate the manufacturing processes. That QS and implementation training would be a flat rate of $2,000.

 

[DrG]

Hello DrG, I am going to assume you are a dentists. Please correct me if I am wrong.

If that is the case, you are not required to have a "quality system" (QS) implemented as the FDA does not regulate the medical or dental practice.

To cover your legal liabilities, I would strongly suggest a QS lite that will document and guide you and your team on the required maintenance on the equipment to assure quality production of the restorations/devices. These tasks will be done and the QS will document the tasks to validate the manufacturing processes. That QS and implementation training would be a flat rate of $2,000.

Tim,
I am a Periodontist who mill custom abutments on the straumann 510k validated workflow. Therefore, do I still need your QS lite?
If I were a dental lab milling the same custom abutments on the same Straumann 510k validated platform, would I have to have a QS?

 

[CoolHandLuke]

Doctors were not supposed under the fda to manufacture their own restorations, which is why theres no regulation.

In order to obtain a proper long term 510k clearance you will need to show how consistent your abutments are, and how substantially similar your abutments are in relation to the original manufacturing geometry.

There are also clearances required for your cad software and cam software.

Ref https://www.aegisdentalnetwork.com/id/2015/06/non-fda-compliant-ti-cadcam-custom-abutments
The FDA regulates CAD/CAM technologies in the dental laboratory under the FDA’s Title 21 CFR 820, which providesa framework for Current Good Manufacturing Practices (CGMP),and quality management procedures used in the manufacturing of Class II medical devices

Per http://www.dentalproductsreport.com...ng-fda-involvement-cadcam-dental-restorations

An article written by tim.

 

[DrG]

Doctors were not supposed under the fda to manufacture their own restorations, which is why theres no regulation.

In order to obtain a proper long term 510k clearance you will need to show how consistent your abutments are, and how substantially similar your abutments are in relation to the original manufacturing geometry.

There are also clearances required for your cad software and cam software.

Ref https://www.aegisdentalnetwork.com/id/2015/06/non-fda-compliant-ti-cadcam-custom-abutments
The FDA regulates CAD/CAM technologies in the dental laboratory under the FDA’s Title 21 CFR 820, which providesa framework for Current Good Manufacturing Practices (CGMP),and quality management procedures used in the manufacturing of Class II medical devices

Per http://www.dentalproductsreport.com...ng-fda-involvement-cadcam-dental-restorations

An article written by tim.

OK , but no one is answering my question:
I am a Periodontist who mill custom abutments on the straumann 510k validated workflow. Therefore, do I still need your QS lite?
If I were a dental lab milling the same custom abutments on the same Straumann 510k validated platform, would I have to have a QS?
I am referring to this document: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171649.pdf

 

[Jason D]

OK , but no one is answering my question:
I am a Periodontist who mill custom abutments on the straumann 510k validated workflow. Therefore, do I still need your QS lite?
If I were a dental lab milling the same custom abutments on the same Straumann 510k validated platform, would I have to have a QS?
I am referring to this document: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171649.pdf

no, you would not require either one, nor would you for sirona or any other 'closed' system.

 

[DrG]

Thank you Jason. This makes sense.

 

[ChrisBWJ]

A little late to the thread here.. What Tim and maybe others have said about the FDA not regulating the practice of medicine is 100% correct.

Now if a doctor "brands" their medical device such as "Dr. X Dental Implant Abutments", then the FDA has jurisdiction because the device is being marketed to the public. There are publicly viewable warning letters on the FDA website when doctors brand their product, advertise their device on websites, infomercials, webinars, etc...

If Dr. X mills abutments and sends them to their colleague across town, the FDA would consider that marketing as well and Dr. X would be subject to FDA registration, QMS, etc...

If Dr. X mills an abutment for a Dr. X's patient without branding or marketing, the FDA considers it "off-label" use of a medical device and the Doctor bears personal responsibility for determining it's use as an appropriate medical device.

If a doctor or lab buys and uses (following the manufacturer's Instructions for Use document) a closed milling system which has a 510k clearance. The doctor nor the lab are required to register with the FDA or implement a formal QMS. The doctor or lab cannot re-brand the abutments and call them something other than the cleared name, otherwise they would be considered a re-labeler in the FDA's eyes and registration/QMS become necessary.

 

[Affinity]

When you say 'mills an abutment' are you talking about Titanium preforms, or milled interfaces from a puck, or both?

 

[DESS-USA]

Preforms since if you are going to mill an interface from a puck you have to go through FDA. For a preform a company such as DESS submits to the FDA and receives "approval" to allow dental labs to utilize the preforms as a DESS Authorized milling provider who make fabricate a custom titanium or chrome cobalt abutment.

 

[Andrew Priddy]

you can find the pre-forms that are cleared on Straumann and Medentica web store..
just select preforms in the drop down..

medentica
https://shop.straumann.com/medentik...i-Unit-Prosthetics/Ti-Forms/c/cat_med_tiforms

for Straumann, go to the specific size in "prosthetic solutions

 

[Tim Torbenson]

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 ?

Hello MrG, Contact me @[email protected] and I will provide you with an extensive list of FDA Cleared Ti Bases and Blanks that are on the market and can be modified in-house using any mill.

 

[Tim Torbenson]

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.

There is a lot of misinformation in the above answer.