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.

 

[Affinity]

Hilarious people still think these 3 letters are looking after peoples health, red dye #3 might be the grenade pin that just got pulled.
Each industry might need to regulate itself with its own professionals, not beuaracracy.
Anyone else noticing a lot of implant failures lately? Not crowns failing, but implants coming out, bone loss, infection etc. With more and more being placed same day the past decade the failure rate is going to rise also. Im redoing a crappy A04 FMR (not mine), one of the implants had to come out, so trash your $50k bridge and start over with an acrylic hybrid, after you pay again to replace the implant... surgeon will call the lab and say, 'did you use authentic parts?'

 

[brayks]

I do not recall seeing this mentioned so I thought I would provide a brief update on what I understand to be the current state of the union.

The FDA has implemented a Plug and Play (PnP) "program" whereby an implant manufacturer is responsible for certifying the work flow for a lab or clinician to produce custom abutments for their 510k cleared premilled/preformed blanks.

This includes machines, CAD software, CAM software, can even be zirconia for the crowns, etc.

Under this PnP workflow the manufacturer of the custom abutment needs no QMS and basically does not come under the scrutiny of the FDA.

In our case, many of our Versamill machines have been or are in the process of being qualified by DESS (for which we are a reseller), Straumann, Medentika, and Preat for their PnP workflows and in many cases we have achieved most favorable status due to quality, reliability and support considerations.

You can contact us for the most current list of Versamill machines and associated implant manufacturers/systems.

 

[sidesh0wb0b]

Hilarious people still think these 3 letters are looking after peoples health, red dye #3 might be the grenade pin that just got pulled.
Each industry might need to regulate itself with its own professionals, not beuaracracy.
Anyone else noticing a lot of implant failures lately? Not crowns failing, but implants coming out, bone loss, infection etc. With more and more being placed same day the past decade the failure rate is going to rise also. Im redoing a crappy A04 FMR (not mine), one of the implants had to come out, so trash your $50k bridge and start over with an acrylic hybrid, after you pay again to replace the implant... surgeon will call the lab and say, 'did you use authentic parts?'

i wish it wasnt so, but it is.
we are starting over on a FMR too (not mine), Ao6 has been failing for 5 years (she is on her 4th) and this poor lady cant get a good product so she switched docs and in turn labs....
in the meantime, 2 of the implants failed and had to be removed. temp locator denture (ours finally) is in place now, she will need some grafts and new surgeries to get at least one of them placed again. such a mess.

 

[Affinity]

It seems almost 1 in 4 or 5 cases with multiple implants that at least one has failed..

 

[sidesh0wb0b]

It seems almost 1 in 4 or 5 cases with multiple implants that at least one has failed..

i wonder if thats due to immediate load, poor aox designs, or something else...

 

[doug]

Poor case planning at the surgical level. I've seen enough un-restored implants fail to know that.

 

[Affinity]

I just did a reline yesterday 2 locators , one got relined back into the denture because it fell out. I guess thats why they call it practicing dentistry..

Im in one today, I walked into my biggest accounts office and all his diplomas were off the wall and the girls tell me 'Doc retired!' One of the best Ive worked with, and for 13 years, but doing teeth in your mid 70s is tough.