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DNA Appliance FDA Warning Letter for termination!!!  

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Wellwellwell
Active Member

So I was looking to get the DNA Appliance and started reading into it. 

I will be honest, there is a great lack of evidence for this device working. I watched a video of the creator of the device Gurdev Dave Singh where he claims the device is FDA approved.

I found the link above because I searched on google FDA and DNA Appliance, this proves that the device is FDA approved but that there are also concerns raised by the FDA that were not answered and a warning letter for termination needed to be issued.

This seems like a warning letter for some of the things they did not address.

I am still going through the research, but I think that this is kind of a red light.

 

Link to FDA warning letter:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biomodeling-solutions-inc-540821-01122018

Link to Vivoslife site showing the company CMO:

https://www.vivoslife.com/our-company.html

 

- Age: 30
- Started soft mewing on 12 Feb 2019. Have not seen any real results or changes.
- Starting IMW: 35 mm
- Current IMW: 35 mm

Quote
Posted : 22/10/2019 12:58 pm
TGW liked
TGW
 TGW
TGW Admin Admin

Sincerely happy that you did the research into the appliance and let the community know about what you found. It is important to be critical of appliances and practitioners, and people like you doing research and sharing with the community is the entire point of why this forum will always remain the best source of information.

To chime in with my own information: This FDA complaint is from Jan 2018, and has since been resolved. Essentially, Dr. Singh made design changes to the materials of the appliance and did not receive confirmation from the FDA before continuing the new materials design. This is essentially the FDA saying "Hey, the way you made this doesn't match up with the way that we have on file - you can not make changes to a dental appliance without us giving the green light"

They later go on to list a larger variety of complaints, but they're largely administrative and protocol complaints for the production lab rather than an indictment of the device itself.

Making no defense of whatever Dr. Singh and his lab(s) did wrong to deserve this complaint by the FDA, he is now partnered with Vivoslife (a health company) and the complaint is essentially null. It's been resolved and they continue to manufacture the DNA and affiliated appliances. 

What is still up for debate is the marketing material and "results" shown, but that goes across the board for all appliances. 

 

ReplyQuote
Posted : 22/10/2019 3:37 pm
Wellwellwell
Active Member

Yeah from the small research I did. It still seems like the most established and backed appliance right now.

- Age: 30
- Started soft mewing on 12 Feb 2019. Have not seen any real results or changes.
- Starting IMW: 35 mm
- Current IMW: 35 mm

ReplyQuote
Posted : 22/10/2019 5:27 pm
MadMaxilla
New Member

it's only a little bit better than traditional acrylic expander, but isn't as good as agga for forward growth and much worse than mse for xpansion

ReplyQuote
Posted : 25/10/2019 10:58 am