ICX implants from Germany

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We have a Dr. that is Russian and she sees lots of patients from Russia and the Ukraine. A patient came in with 2 implants from Medentia which I understand is owned by Straumann. I found the ICX implant and parts in their catalog. I also found Dess sells part for it in Europe. Now I assume the impants are not for sale in the US because they haven't be certified by the ADA. Is it possible to buy parts for that system? Is it legal? Has anyone had to deal with these implants and were you able to get the parts? Thanks.
 
From their page so dont think they have any kind of FDA certification Deutschland, Österreich, Schweiz, Ungarn, Italien, Kroatien, Serbien, Kosovo, Mazedonien, Bosnien-Herzegowina, Slowenien, Albanien, Montenegro, Polen, Tschechien, Bulgarien, Ukraine, Litauen, Lettland, Estland, Belarus, Rumänien, Moldawien, Armenien, Azerbaijan, Georgien, Turkmenistan, Usbekistan, Kasachstan, Kirgisistan, Tadschikistan, Niederlande, England, Türkei, Russland, Griechenland, Irak, Libyen, Thailand, Algerien, China, Iran, Saudi-Arabien, Irland, Finnland, Indien, Sri Lanka, Nepal, Bangladesch, Myanmar, Ägypten, Spanien
 
As i understand Medentica is a basically a sub-brand of Straumann.

Their Medentica CX-Series is compatible with the mentioned ICX implant system ( the implant itself shouldn't be by medentika it should be medentis icx, only the abutments/build ups should be by medentika) .

unfortunately, as mentioned here > https://dentallabnetwork.com/forums/threads/medentis-medical-available-in-the-us-compatibles.32763/

there's probably no US reseller for those ( same for dess as it seems, and arumdental also only EU, henry shein has premilled ICX abutments too ).
 
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I tried Dess to see if we could get them from Europe and the answer is no. Not legal in the US.
 
In my mind, there should be a way you can enquire an exception request to your USA authorities, or is the patient expectet to be left dying just because he got treated outside the US before?

I'll give Medentika Germany a call today, we order there.
Maybe they have a tip.
 
The Dr. trying to work something out. I'm out of the loop now. I was spending too much time trying to find a solution. I feel bad for the patient but I can't spend hours on the internet and phone for nothing.
 
Medentika was bought by Straumann many years ago. Production and development are still separate. Medentika is extremely innovative, especially in the area of digital solutions. The founder of Medentika still heads the business unit today. Straumann is so smart and lets the companies continue to run as successfully as they became. Integration into the big parent company is done very carefully. It is amazing what Straumann owns.
They also have a large stake in Rapidshape. But the founder of RS still has the majority.
DESS is a great product. But the tolerances are noticeably larger than in the original.
 
As expected no detailed information by phone, german workers do not know USA Regulations ofc.
I would have to contact Medentika by email.

You can give me a pm if we want to dig deeper.
 
Thanks for the offer but the Dr. is going to try on her own. I really don't want to get involved. I've lost too much time on this already.
 
You can buy Medentica parts from Abutment Direct located in Toronto, Canada
 
You can buy Medentica parts from Abutment Direct located in Toronto, Canada
No Medentika CX Series in USA M8, that's the whole problem here ( german implant Medentis ICX with Medentika parts Europe only )
 
We had a similar situation with not being able to get Medentika parts. Even our Straumann rep could not get parts for us. Patient has to go back where they got the implant from to restore.
 
Unfortunately the patient we're dealing with is from the Ukraine.
 
I'm from Germany and don't know the laws in the USA. I have the following question:
Is a dentist allowed to use material on a patient that the patient himself bought abroad?
 
I would guess not since the items are not FDA approved. We never encountered this issue.
 
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