Want to become 510K compliant with teh FDA?

[BobCDT]

Hi All,
A close friend has been working to develop a new dental lab startup for some time. The company, evo820 is here to help any lab interested in becoming FDA compliant. Currently, this comes into play for labs milling custom abutments and or manufacturing surgical guides for implants. It is expected, over time, that the FDA will become more controlling of DT. The evo820 business model is to help labs get over the FDA hurdles that have come into play over the last 18 months. The cost seems very reasonable the service and product are relatively turnkey.
BTW, I have zero interest in this company, What Tim has done is what so many of us can benefit from having. I just felt like you all should know about it.
You can check them out here: evo820.com

 

[Affinity]

Did I miss something, do you currently need FDA compliance to mfg surgical guides? Or is this coming? Thanks for the link.

 

[BobCDT]

Did I miss something, do you currently need FDA compliance to mfg surgical guides? Or is this coming? Thanks for the link.

If the guided is planned with a surgical guide software that merges a CBCT scan with a surface scan and planned on a computer, it's a medical device requiring the lab to be registered with the FDA as a medical device manufacturer. This product is classified like a milled custom abutment.

 

[Affinity]

I dont see that this is being enforced, every dentist with a cheapo printer is doing this everyday, 1000s of cases daily through BlueSky alone..

 

[2thm8kr]

I dont see that this is being enforced, every dentist with a cheapo printer is doing this everyday, 1000s of cases daily through BlueSky alone..

Different game if you are the dentist and making it in house for your patient.

 

[BobCDT]

I dont see that this is being enforced, every dentist with a cheapo printer is doing this everyday, 1000s of cases daily through BlueSky alone..

Dentists don't need the FDA compliance to plan and or produce guide. LABS DO. BlueSky must be a registered medical device manufacturer.

 

[Ken Knapp]

Hi All,
A close friend has been working to develop a new dental lab startup for some time. The company, evo820 is here to help any lab interested in becoming FDA compliant. Currently, this comes into play for labs milling custom abutments and or manufacturing surgical guides for implants. It is expected, over time, that the FDA will become more controlling of DT. The evo820 business model is to help labs get over the FDA hurdles that have come into play over the last 18 months. The cost seems very reasonable the service and product are relatively turnkey.
BTW, I have zero interest in this company, What Tim has done is what so many of us can benefit from having. I just felt like you all should know about it.
You can check them out here: evo820.com

Bob, does this include the State requirements for FDA compliance, such as the California State Food and Drug Branch. I have found the CA FDB requires a lot more work than the FDA.

 

[Doris A]

So if a Dr asks for a clear duplicate denture or partial that he is going to use for a guide, that he put the holes in, do we still need to be FDA compliant?

 

[2thm8kr]

No

 

[JMN]

So if a Dr asks for a clear duplicate denture or partial that he is going to use for a guide, that he put the holes in, do we still need to be FDA compliant?

Same as abutments. Mill it with a machine, you need FDA. Do it by hand, not required.

 

[BobCDT]

Bob, does this include the State requirements for FDA compliance, such as the California State Food and Drug Branch. I have found the CA FDB requires a lot more work than the FDA.

I am not up on CA regs. Tim is from CA, I would contact him at eov820.

 

[BobCDT]

So if a Dr asks for a clear duplicate denture or partial that he is going to use for a guide, that he put the holes in, do we still need to be FDA compliant?

No, only if you do planning and guide production with a "guided planning software".
A suck down or dupe is OK as far as I know.

 

[Affinity]

what is the difference between a Dr making it and a lab, if the Dr dont fulfill the requirements of the FDA? This makes no sense, just more regs.

 

[rkm rdt]

what is the difference between a Dr making it and a lab, if the Dr dont fulfill the requirements of the FDA? This makes no sense, just more regs.

I know someone with a workaround

 

[BobCDT]

what is the difference between a Dr making it and a lab, if the Dr dont fulfill the requirements of the FDA? This makes no sense, just more regs.

A lot of things the government does do not make sense. I think the medical license that a dentist holds is adequate for FDA. The FDA is currently looking at labs, not dentists. I also believe the dentist can legally mill custom abutment without a GMP or registering with the FDA.

 

[2thm8kr]

I also believe the dentist can legally mill custom abutment without a GMP or registering with the FDA.

I have to question this since Sirona put so much money and effort into making their chair side system FDA compliant for milling abutments.

 

[BobCDT]

Yes, the system is compliant for milling CA's. This was for Sirona to get into more labs. Even with Cerec, a lab will still need a GMP with proper record keeping.

 

[2thm8kr]

There are other chair side systems, not looking at getting into the labs, that don't advertise CA's because their system isn't FDA blessed.

 

[BobCDT]

I really don't want to argue about FDA, who needs it and who does not.
Currently, if a lab wants to be involved in milling CA's and or Guided Surgery, legally they need to be registered as a medical device manufacturer with the FDA. With this registration comes a lot of new responsibilities that most labs are not up to. Hense evo820 can help with all this. In addition, once registered it is very likely that the FDA will visit a registered facility within two years to ensure you are following proper process. If not, there are fines to pay and the FDA can shut down businesses.

 

[2thm8kr]

Whose arguing? I'm just questioning whether a Dentist has to have an FDA compliant means to make custom abutments.