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Manufacturing equipment (e.g.: Dental Welder): medical device or not?

PacoRabanez

Starting to get Involved
#1
Hi to everyone.

I hope you all are well and fine.

I came across a particular topic and, I think, also widespread.
I searched over the forum but didn't find anything.


There is an equipment used to manufacture a medical device.
In particular, an arch welder to fabricate a dental titanium prosthesis.

Is this welder a medical device in the USA?
I cannot find anything across the FDA product code database or into their guidances.

My opinion is that a "simple" welder is not a medical device, but it is up to the manufacturer qualify and validate the process, the equipment and the related supplier.
So, the supplier have "no" responsabilities in term of USA regulation under FDA.


I would appreciate a lot if some of you experts could share any opinion (or material reference or experience too).

Thank you very much.
 
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Al Rosen

Staff member
Super Moderator
#2
Hi to everyone.

I hope you all are well and fine.

I came across a particular topic and, I think, also widespread.
I searched over the forum but didn't find anything.


There is an equipment used to manufacture a medical device.
In particular, an arch welder to fabricate a dental titanium prosthesis.

Is this welder a medical device in the USA?
I cannot find anything across the FDA product code database or into their guidances.

My opinion is that a "simple" welder is not a medical device, but it is up to the manufacturer qualify and validate the process, the equipment and the related supplier.
So, the supplier have "no" responsabilities in term of USA regulation under FDA.


I would appreciate a lot if some of you experts could share any opinion (or material reference or experience too).

Thank you very much.
The arc welder is not a medical device. How to Determine if Your Product is a Medical Device

It is not
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,


or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals
 

PacoRabanez

Starting to get Involved
#3
The arc welder is not a medical device. How to Determine if Your Product is a Medical Device

It is not
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,


or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals

Hi.
Thank you very much for sharing your opinion and point of view.

Its intended use (fabrication of dental device) made me confused, but, indeed, basing on the definition this arc welder is not a MD if not used on a patient.

Many thanks.
 

PacoRabanez

Starting to get Involved
#4
The arc welder is not a medical device. How to Determine if Your Product is a Medical Device

It is not
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,


or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals

Hi. I would like to share an update:
searching again into the FDA product code database, I came over this one NDP:
Device Accessories, Implant, Dental, Endosseous
Regulation Description Endosseous dental implant accessories.
Product Code NDP
Submission Type 510(K) Exempt
Regulation Number872.3980
Device Class 1

If you read the regulation number description:

Sec. 872.3980 Endosseous dental implant accessories.
(a) Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.


My question is:
Does this product code include the aforementioned arc welding machine?
or is this product code only for specific accessories to a specific medical device?
e.g.: a specific dental medical device needs the use of a specific accessory (such as aspecific arch welder).
 

Al Rosen

Staff member
Super Moderator
#5
Hi. I would like to share an update:
searching again into the FDA product code database, I came over this one NDP:
Device Accessories, Implant, Dental, Endosseous
Regulation Description Endosseous dental implant accessories.
Product Code NDP
Submission Type 510(K) Exempt
Regulation Number872.3980
Device Class 1

If you read the regulation number description:

Sec. 872.3980 Endosseous dental implant accessories.
(a) Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.


My question is:
Does this product code include the aforementioned arc welding machine?
or is this product code only for specific accessories to a specific medical device?
e.g.: a specific dental medical device needs the use of a specific accessory (such as aspecific arch welder).
Caveat: I'm not an expert on Dental tools so this is just my opinion.

I highlighted the salient point in the quote above. It is not manually powered nor is it any of the items listed. Based on this, I think it is not an accessory.
 

PacoRabanez

Starting to get Involved
#6
Caveat: I'm not an expert on Dental tools so this is just my opinion.

I highlighted the salient point in the quote above. It is not manually powered nor is it any of the items listed. Based on this, I think it is not an accessory.
Thank you again very much.
Very kind of you.
 
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