Straumann Headaches...

[RJS8669]

So, for the past couple of weeks (using 3Shape 2016),I have set up Trios Scan orders to enable me to design a Straumann Abutment (or milled crown) and output a printed model simultaneously. Out of nowhere, I started getting my abutment and restoration files kicked back by Straumann as "unable to manufacture" because of the model being selected in the order form. The incredibly rude woman who explained this to me said that it wasn't a Straumann issue, but a 3Shape issue, and stated something about the model not being FDA compliant.

Since when does a model have to FDA compliant?

Anyway, wanted to know if anyone else has run into this. The workaround seems to be to set up the order without the model; design and send the abutment; then make a new order with the model. Extra work which just seems ridiculous....

 

[rkm rdt]

Are they printing your models?

I used their scan body for an rc the other day but the software shows a different scan body to align to. wtf?

Straumann is so far behind the other companies today. I feel your pain.

 

[JohnWilson]

is this something you are milling in house or something you sent to them?

 

[ts4341]

I can't design Neoss abutments anymore with the 2015 6.1
I get the same FDA warning.. CMC can't figure how to make it work??

 

[grantoz]

i think fda is going to play a bigger and bigger part in all the stuff we make right down to the models its a pain but unavoidable this is what implant companies want so you have to use them for everything.straumann has been pushing using genuine for years this is another new way of doing this. sirona is doing similar stuff with abutments and now they are even bigger with sirona astra and dentsply being the same group i think its going to get worse.

 

[doug]

The models don't get delivered to the patient. What would be the reasoning for the FDA controlling anything more than the material?

 

[eyeloveteeth]

this is precisely why I have so much beef with the way Straumann and Biohorizons set up their libraries. Zimmerbiomet is so far the most easy to work with in terms of pulling data and information.

Instead of making implant models with analogs we just mill models with the abutment design as dies.

Straumann and probably a few other companies work their files in a way that makes that more difficult. (for the prying eyes, you CAN align XYZ in 3Shape Configurations, but you need to know the values)

 

[JohnWilson]

The model is not what is causing the issue, its the local milling that they are trying to eliminate as the library is not certified.

Everything can be done if you know how.

You just have to set up dual manufacturing process for split file if you are printing your own models. Jeff give me a call if those Straumann does not help you out

 

[RJS8669]

is this something you are milling in house or something you sent to them?

Having them mill - 2016 kinda shuts down in-house milling.

 

[WDL-Cali-Cad-Man]

The model is not what is causing the issue, its the local milling that they are trying to eliminate as the library is not certified.

Everything can be done if you know how.

You just have to set up dual manufacturing process for split file if you are printing your own models. Jeff give me a call if those Straumann does not help you out

Hi John. i'm having issues with the 3D model printing in house. the models print fine but we have had Dr's saying the abutment is way too short+ the crown and the analog is deeper in the 3d model than whats in the mouth. it seems to happen alot with straumann scans via itero and Elos. Any tips or help would be great

 

[kcdt]

I can't design Neoss abutments anymore with the 2015 6.1
I get the same FDA warning.. CMC can't figure how to make it work??

It not a make it work issue; it's a legality issue governing medical devices.

 

[victormasi]

So does Exocad have the same blocks on sending files to non FDA approved milling centers?

 

[2thm8kr]

exocad ≠ blocks

 

[MetalMachine]

Anyone else having problems with milled emax crown + straumann one-piece abutment? 3Shape 2016 has a bug that creates "reverse cement gap" on abutment at the end of designing so crown won't fit. They told it might be fixed on 2017 version, but has it? Or is there any way to avoid this? Straumann sales rep told I'm the only one with this problem but I heard from third party it's well-known problem. It took months before Straumann admitted there is something wrong and now neither Straumann nor 3Shape feel eager to fix it.

Here is my pretty drawing:
View media item 166

 

[shane williams]

I was wondering if anyone has heard of someone unlocking the Straumann material so that we can mill in-house using the 2016 software. I would really love to have all my scanners on the same version, but with not being able to mill out the variobase zr units I can't switch from 2014 to 2016. Also in the '14 software I'm able to change from one scan body to another. If a doctor is using a glidewell scanbody, and I need to make a model, after I accept it and set the insertion, I can change it to a system that allows for a digital analog in a model. But if I could find a way to unlock the straumann materials and allow me to mill that would be awesome!!!!

 

[BobCDT]

Currently, the FDA has classified Custom abutments as a class 2 device. Surgical guides are Class 1. Snore appliances are class 2. Nothing else, to my knowledge, has been regulated but I think everything that is screwed directly to the implant will become a class 2 device. This would include bars and screw retained crowns (direct to implants, no abutment).
Class 2 you need a 510k.
Class 1 you need to register with FDA as a medical device manufacturer and do everything needed for Class 2 with the exception of the 510K.
No models are not medical devices and it's extremely unlikely they will ever become a medical device.

 

[JMN]

Currently, the FDA has classified Custom abutments as a class 2 device. Surgical guides are Class 1. Snore appliances are class 2. Nothing else, to my knowledge, has been regulated but I think everything that is screwed directly to the implant will become a class 2 device. This would include bars and screw retained crowns (direct to implants, no abutment).
Class 2 you need a 510k.
Class 1 you need to register with FDA as a medical device manufacturer and do everything needed for Class 2 with the exception of the 510K.
No models are not medical devices and it's extremely unlikely they will ever become a medical device.

For clarity, surgical guides made by mill are Class 1, or all of them even if made by hand and handpiece?

 

[BobCDT]

For clarity, surgical guides made by mill are Class 1, or all of them even if made by hand and handpiece?

just the guides that include planning from a CBCT scan and surface scan to align drilling holes.

 

[JMN]

just the guides that include planning from a CBCT scan and surface scan to align drilling holes.

Thanks, rather be sure.

 

[a3dl]

Older Thread. But running into some issues with dr sending ios scans with straumann scan marker. I can not print my own model of the ti base set into model. Does anyone have a workaround for this? We are using exocad and modelcreator.