Ann: FDA Clearance for O2Vent Optima Oral Device, page-19

Oventus already had 2 similar MAD devices approved by the FDA , my understanding is the main difference with this approval was that the Optima was made out of nylon type material not Titanium and plastic (composite )
I doubt there was a change in any efficacy , as the Optima airways I have been told give the same efficacy as the titanium device .
The Opitima also is ready made to accept the exvent which is still awaiting FDA approval , whereas some of the earlier Oventus MAD devices would not accept exvent
I believe Somnomed already had a similar device approved with the same material so to me the Optima probably just needed to be rubber stamped .
The above is just my opinion and I have no professional knowledge on Oventus