Validated Milling Center or Implant Companies not selling new products

[Contraluz]

I posted something along these lines before, but can't find the thread. But get ready, you will be cut off the supply line...

Keystone has new products, but wont sell them to labs unless they go through the process of becoming a 'Validated Milling Center'.

Has any of you gone through the process? Apparently this will be with all new FDA approved products and parts. It can't be sold to non compliant labs. Older parts were 'Grandfathered' in, according to the Guy I spoke to.

Funny enough, the new product seems to be DESS' AngleBase Ti base for the keystone platform...

 

[TheLabGuy]

Never heard of this. I know some companies want you to use a 'preferred' lab...but that's because some things are technique sensitive but haven't heard this new FDA angle yet.

 

[Contraluz]

Never heard of this. I know some companies want you to use a 'preferred' lab...but that's because some things are technique sensitive but haven't heard this new FDA angle yet.

Same here, Keystone is the only company, so far.

 

[Foggy_in_RI]

I wonder if they know something is changing in the near future (from a manufacturing/distributor perspective)

How many unregistered labs are working with abutments and implants today??? Probably too many...

FDA Regulations of Customized Abutments | Open Implants

By: Gregg M. Gellman As the Chief Executive Officer of Open Implants and new to blogging, I suddenly feel inspired and obligated to share what we have learned about the FDA. […]

www.openimplants.com

FDA Expands Laboratory Requirements | Inside Dental Technology

CAD/CAM capabilities can mean increasing oversight

www.aegisdentalnetwork.com

 

[Contraluz]

How many unregistered labs are working with abutments and implants today??? Probably too many...

Maybe 99%?

 

[sidesh0wb0b]

I posted something along these lines before, but can't find the thread. But get ready, you will be cut off the supply line...

Keystone has new products, but wont sell them to labs unless they go through the process of becoming a 'Validated Milling Center'.

Has any of you gone through the process? Apparently this will be with all new FDA approved products and parts. It can't be sold to non compliant labs. Older parts were 'Grandfathered' in, according to the Guy I spoke to.

Funny enough, the new product seems to be DESS' AngleBase Ti base for the keystone platform...

what new products does keystone have that they wont sell? unless its only the DESS parts
weird

 

[Contraluz]

what new products does keystone have that they wont sell? unless its only the DESS parts
weird

I'll know shortly, the parts can be sold to the Dentist.

I don't think it matters what sophisticated or unsophisticated part it is. What matters is the date it was FDA approved...

 

[doug]

I sat through Tim Torbenson's presentation in Chicago and don't recall my having to meet any particular criteria. I do have to deal with a milling center that is FDA cleared and has validated their workflow. If I start providing some items that are classified differently that might change. I may call hime tomorrow to get clarification,

 

[TheLabGuy]

I'll know shortly, the parts can be sold to the Dentist.

I don't think it matters what sophisticated or unsophisticated part it is. What matters is the date it was FDA approved...

I think the only thing i haven't been able to purchase from any supplier Dentist related was I had one silly implant company not sell me the actual implant. Which i get, they only want to sell to someone placing the implant...but I was confirming some stuff I was getting back from a milling center so I wanted the actual implant. So I had one of my Docs drop ship it to my lab for me...so there Straumann, sit and spin fkrs.

 

[Contraluz]

I think the only thing i haven't been able to purchase from any supplier Dentist related was I had one silly implant company not sell me the actual implant. Which i get, they only want to sell to someone placing the implant...but I was confirming some stuff I was getting back from a milling center so I wanted the actual implant. So I had one of my Docs drop ship it to my lab for me...so there Straumann, sit and spin fkrs.

Keystone would not allow drop ship... Quite silly, if you ask me.

 

[Gru]

I can't think of a good reason why anyone would want to work with Keystone. My limited experience with them makes me glad it's been limited.

 

[sidesh0wb0b]

I'll know shortly, the parts can be sold to the Dentist.

I don't think it matters what sophisticated or unsophisticated part it is. What matters is the date it was FDA approved...

wow, please keep me posted sir!

 

[sidesh0wb0b]

I can't think of a good reason why anyone would want to work with Keystone. My limited experience with them makes me glad it's been limited.

keystone platforms are 80% of what i get in the door lately. they arent too terrible i suppose

 

[Contraluz]

keystone platforms are 80% of what i get in the door lately. they arent too terrible i suppose

Not at that level, but I have one client that almost exclusively uses Keystone, plus the ocasional case here and there. The thing is, there are a whole bunch of other brands under the Keystone umbrella, like Paltop, Zeramax and others. I do get a fair share of Paltop cases, so this will have an impact there, too.

 

[sidesh0wb0b]

Not at that level, but I have one client that almost exclusively uses Keystone, plus the ocasional case here and there. The thing is, there are a whole bunch of other brands under the Keystone umbrella, like Paltop, Zeramax and others. I do get a fair share of Paltop cases, so this will have an impact there, too.

interesting. ben getting a bunch of paltop in the last few months too. those i really dont enjoy working with lol

 

[FASTFNGR]

I posted something along these lines before, but can't find the thread. But get ready, you will be cut off the supply line...

Keystone has new products, but wont sell them to labs unless they go through the process of becoming a 'Validated Milling Center'.

Has any of you gone through the process? Apparently this will be with all new FDA approved products and parts. It can't be sold to non compliant labs. Older parts were 'Grandfathered' in, according to the Guy I spoke to.

Funny enough, the new product seems to be DESS' AngleBase Ti base for the keystone platform...

This info showed up about 3 to 5 years ago saying that not anyone can mill a titanium base unless certified by a FDA or some other branches of the government department. This is why I buy stock and customize them the way I want. It is not the cheapest way but it is peace of mind for me.

 

[Contraluz]

This info showed up about 3 to 5 years ago saying that not anyone can mill a titanium base unless certified by a FDA or some other branches of the government department. This is why I buy stock and customize them the way I want. It is not the cheapest way but it is peace of mind for me.

The thing is, the part that was not sold to me is a stock abutment, from DESS. But with the Keystone interface... And Keystone wont sell you any new parts, unless you are a Validated lab. Older parts are apparently grandfathered in.

 

[Contraluz]

wow, please keep me posted sir!

So the abutment in question seems to be an 'AngleBase' from DESS, although not with the 'Dess' Screw. Package is Keystone packaging.

 

[Toothman19]

I thought you were talking about keystone resins at first....

 

[Contraluz]

I thought you were talking about keystone resins at first....

That may be the next step…