Dentistry Archives

Medgadget has learned that Ultra Suction™ denture system, originally mentioned by us in February, has finally secured FDA approval.
From the press release by Biomedics NZ Limited:

A New Zealand based company, Biomedics NZ Limited reports that it has obtained FDA approval for its Ultra Suction™, complete denture stabilizer system.
Biomedics NZ reports that Ultra Suction™ system comprises a tiny unidirectional device that is imbedded into a denture plate. As the denture wearer bites firmly, the air trapped between the gum and the denture is expelled through the device, via two air passages. The lower pressure obtained beneath the denture tends to exert a pull and helps secure the denture against the gum. Properly fitted dentures can increase wearing comfort, the ability to chew and therefore impact on the overall health of the patient.

Consider reading the original post on Ultra Suction™, as it contains some valuable comments from Mony Paz, M.D., the inventor of the device.

The new IntelliClean system from Sonicare and Crest, and manufactured by Philips is the first integrated power toothbrush and toothpaste dispensing system.
From the product’s website:

Read More

The American FDA wields some power over approving medical devices. It’s certainly less stringent than their regulatory power over drugs, but sometimes there’s a subtle distinction between what constitutes a drug or device. Here’s some insight into how regulators decide, via a Reuters story about the Decapinol oral rinse:

The oral rinse is being regulated as a medical device and not as a drug because its primary mode of action is to create a physical barrier, rather than to act chemically. The product contains a surfactant that acts as a physical barrier, making it harder for bacteria to stick to tooth surfaces. FDA also has approved a number of other anti-gingivitis oral rinses, but since these products act chemically to kill bacteria that live in the mouth, they are regulated as antimicrobial drugs rather than as devices.

Read More

Israel21c reports that a new start-up Tactile Technologies recently obtained US Food and Drug Administration marketing approval for its dental implant location software. The software is a three-dimensional solution for surgical planning. From the article:

The company’s flagship product, which is in the final stages of development, is an Implant Location System (ILS) that uses a disposable micro-robot for carrying out dental implant procedures. The company promises that when this product hits the market, the process of getting dental implants will be less painful and less expensive.

Read More