ISO 13485 scope (implantable) - Polymers for dental application

[Daliane]

Hi all
My client is a Virtual Manufacturer of a polymer that is used for dental application with 3D printing technology. The polymer is sold to dental labs to print temporary implants (use up to 1 year) and dental bridges.
They don't manufacture this polymer, but get the ready bottles with content from the OEM. The polymer itself is class I.

I need help to assess whether it falls under following requirement of ISO 13485 section "7.5.9.2 Particular requirements for implantable medical devices"?

Thanks!

Regards
Daliane

 

[indubioush]

Did you read section 3.6 of ISO 13485?

 

[Daliane]

Did you read section 3.6 of ISO 13485?

Yes I understand that. The client is selling the polymer. The lab they are selling it to is printing the implants by themselves using that polymer.

 

[planB]

I need help to assess whether it falls under following requirement of ISO 13485 section "7.5.9.2 Particular requirements for implantable medical devices"?

Daliane,

as @indubioush pointed out: if your device falls under the definition ISO 13485, section 3.6, then yes, section 7.5.9.2 also applies to your device.

Hope this helps,

 

[Daliane]

Ok maybe I should clarify my question: I need help to determine if this resin is applicable to the definition in section 3.6
We declare that this resins can print dental bridges. But we don't sell the dental application, only the resins itself.

Any idea someone?


Thanks a lot!

 

[somashekar]

Ok maybe I should clarify my question: I need help to determine if this resin is applicable to the definition in section 3.6
We declare that this resins can print dental bridges. But we don't sell the dental application, only the resins itself.

Any idea someone?


Thanks a lot!

NO. It does not.
7.5.9.2 can be your non-application
Your product / service is far from being what is said in 3.6 of terms and definitions.

 

[monoj mon]

Although it looks like the resin doesn't fall under the section 3.6, but I feel like it is not that simple. As @Daliane has said and I quote

The polymer is sold to dental labs to print temporary implants (use up to 1 year) and dental bridges.

It is already intended as dental implant, the only difference is the user (dental lab) needs to give it a shape using a 3D Printer! What about "Bone Cement"! Are the ingredients considered to be under Section 3.6! Does anyone has any experience with it! I am just curious.

 

[planB]

Daliane,

you originally stated that your resin is a class I medical device. I assume you have an associated biocompatibility report on file? If yes, how did you categorize your device from an ISO 10993-1 perspective in terms of nature and duration of body exposure?

 

[QM_123]

Daliane,

Yes it is dental resin, you sell it to labs and they use 3D printers to make a final device (dental bridge). I think this is Class IIa device. Most probably you identified intended use as "dental bridge" in IFU . As planB said, you check your device category in terms of biocompatibility. On the other hand, I suggest you to check any equivalent device's IFU, if you are not sure. In this scope, I think 7.5.9.2 is applicable for your device. Your processes to produce your resin is important for safety and performance of the final device (dental bridges). For example, if you use wrong raw material or wrong mixture rates for resin that may cause non-biocompatible device.

 

[Daliane]

you originally stated that your resin is a class I medical device.

Yes it is dental resin, you sell it to labs and they use 3D printers to make a final device (dental bridge). I think this is Class IIa device.

Sorry my bad.
The resins for dental applications are class I. The ones for temporary use in the mouth like bridges and implants are definitely class IIa.

Thanks for your feedback guys!

Regards
Daliane