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

D

DrG

Member
Full Member
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 ?
 
T

Tim Torbenson

Member
Full Member
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.
 
D

DrG

Member
Full Member
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

CoolHandLuke

40% titanium
Staff member
Full Member
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/lab/article/increasing-fda-involvement-cadcam-dental-restorations

An article written by tim.
 
D

DrG

Member
Full Member
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/lab/article/increasing-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
 
Last edited:
Jason D

Jason D

Well-Known Member
Full Member
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.
 
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