bar question

[JMN]

Based on your statement I conclude that you are not a Lab owner. If I buy a car than I do this for my personal needs and pleasure and do of course my diligence too.

When I sell crowns, bridges, bars, etc. to my customers then I am responsible for those dental restorations that are considered medical devices and therefore must meet U.S. Food and Drug Administration requirements. This includes registration of establishment, listing of devices, 510(k) approval, etc. If CMC can certify the manufacturing process of their products then it would be less concern. Until now CMC is neither ISO nor DAMAS certified.


Ultimately, it’s up to you where you outsource your bar or restorations.

FDA and DAMAS/ISO are very different things. If it is FDA 510(k) certified it is legal to sell in the USA. Having a different standard in what you sell, as long as the legal and moral obligations are met is not wrong, just different. As you said, you are welcome to yours and everyone else to theirs.

However, if that additional layer of certification given by ISO/DAMAS to the place and process making your restoration is what you want, that's fine too.
Just be willing to pay extra for it.

 

[Periodent]

FDA and DAMAS/ISO are very different things. If it is FDA 510(k) certified it is legal to sell in the USA. Having a different standard in what you sell, as long as the legal and moral obligations are met is not wrong, just different. As you said, you are welcome to yours and everyone else to theirs.

However, if that additional layer of certification given by ISO/DAMAS to the place and process making your restoration is what you want, that's fine too.
Just be willing to pay extra for it.

well said!

 

[JMN]

well said!

Thank you.

 

[kcdt]

Based on your statement I conclude that you are not a Lab owner. If I buy a car than I do this for my personal needs and pleasure and do of course my diligence too.

When I sell crowns, bridges, bars, etc. to my customers then I am responsible for those dental restorations that are considered medical devices and therefore must meet U.S. Food and Drug Administration requirements. This includes registration of establishment, listing of devices, 510(k) approval, etc. If CMC can certify the manufacturing process of their products then it would be less concern. Until now CMC is neither ISO nor DAMAS certified.


Ultimately, it’s up to you where you outsource your bar or restorations.

You seriously need to drop the holier than thou crap.
You've made misstatements and are now jumping to conclusions about folks you know nothing about.
Stop being an asshat

 

[cadfan]

you're kidding me right? So you're telling me that you expect BMW to tell you that their headlights were made in China and the farm your leather came from?

As long as it's compliant, of the quality you expect and that they are willing to take on all responsibility for what they bill out - why does it matter?

This has nothing to do with HS/Zahn being global about anything.

As far as i know BMW build their cars by their own so maybe a lame duck.

 

[JKraver]

As far as i know BMW build their cars by their own so maybe a lame duck.

I wouldn't imagine they would make every part of their cars, not in the global economy.

 

[Beatrice]

to the OP :
You could also support a sponsor of this forum like me and send the bar to me Panthera Dental.
As far as I know we are still the only company that never said NO to a single bar case.,

Still try to understand why bother with other bar manufacturer (ohh price is not the answer I sell in the same price range)