Update: This has been confirmed!
I am a big fan of ozone use for dental treatment and think its a great modality when used for its intended purposes. Kavo has for years been waiting for FDA approval for their Healzone unit. The Healzone has been available for the rest of the world.
A rumor I heard from multiple sources (including a Kavo representative) is that the Healzone will no longer be available world wide because of low sales and no FDA approval. The biggest problem with the device was trying to get a good seal so that the unit would dispense the ozone. There are other ozone machines on the market but none are as nicely built and none have FDA approval. Too bad about the Healzone but ozone therapy has been around for decades and it has a small but very devote following in dentistry.