Locator Abutment

[gacris]

A doctor sent a case requesting a custom locator abutment. I’ve reached out to several local techs and no luck so far. I’ve only done custom abutments. Not locator abutments. I’m just not as familiar with them. The doctor doesn’t want a stock abutment because he feels the angle of the implant is too much. Any advice will be greatly appreciated. The implant is a Nobel replace. (I think. I’m not at the lab right now)

 

[PRO ARTS DL]

TruAbutment makes custom locator abutments

 

[gacris]

TruAbutment makes custom locator abutments

 

[gacris]

Thank you!

 

[keith goldstein]

I have 15 degree angled locators with 1.5 and 3mm collar heights. Make sure the doctor knows that a custom locator is not FDA approved so you are not liable if there is failure.

 

[lcmlabforum]

Custom parts need FDA approval now? UCLA crowns have been done since long time ago so I don't see what is the issue, maybe I am dumb.
Also, check out the angled MedentiLOC - off the shelf and compatible with Locator inserts.
LCM

 

[DESS-USA]

Any part that goes into the mouth for more than 30 minutes requires FDA "approval". They are connected into or onto an implant, touch bone or tissue, and are either temporary or permanent solutions. The part that you casted with such as an all plastic abutment or a UCLA gold adapt abutment or chrome cobalt abutment all where supposed to go through the FDA approval process as well as the screw that connects this. The instructions for use document is also supposed to be submitted to the FDA and MSDS to ensure that the materials that the product is made of as well as the the materials that are to be used by the lab/dentist are approved to be used with part. The issue with any part is biocompatibility, cleanliness of the product that is being made (if you are making a custom part what steps do you go through to ensure that the product is properly cleaned, and is the part that is being made going to last in the mouth permanently without failure. This is why you see that companies are producing 15 degree angled locators and that is as extreme of an angle they are allowed to make them per FDA and also knowing that past that it risks failure or other issues.

 

[Darwin Bagley CDT]

Keith,
Do you mean only the supplier/manufacturer of the raw UCLA abutment is required to have the FDA 510K?
Or are you saying the lab that casts to the UCLA abutment is also required to have the FDA 510K?

Thanks,

Darwin

 

[DESS-USA]

Darwin -
The supplier has to have FDA 510K for the part.
Regarding the lab there is no 510K/FDA that they can obtain.
They can have a quality management system in place that will be utilized during a FDA audit and they can reference the parts they are using as part of that QMS but with these measures in place they are not provided with a 510K number, etc.

However when it comes to utilizing tibases or milling custom titanium abutments using premills in the lab the supplier/manufacturer's 510K will state they (the lab) has the authority to do so because the lab is a validated milling center for manufacture. Please see this 510K under Indication for Use Statement -

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191986.pdf

There are 510K's from other implant part manufacturers/distributors/resllers/milling centers which specifically state that they are the only one's who can use these parts in their facility and no one else. This is why all labs should be reading the 510K documents to ensure that the parts they are using have a 510K.

Thanks,
Keith