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FDA takes a good look at fake saliva.
Dental products advisors to vote on how to classify electrical anesthesia, root canal cleanser.
October 10, 2005: 3:09 PM EDT
By Aaron Smith, CNN/Money staff writer.

NEW YORK (CNN/Money) - There's a market for artificial saliva, in case you didn't know, and it's finally captured the attention of the FDA.

Artificial saliva is for sufferers of xerostomia, also known as dry mouth, a condition that is often a side effect of chemotherapy and various drugs, including antidepressants, antihistamines and diuretics. It can also be caused by stress, anxiety and depression. Not only does the condition cause quality of life problems by affecting speech, taste and diet, but it can interfere with dental prosthesis.

The Food and Drug Administration's advisory panel for dental products will meet Tuesday and Wednesday to vote on how to classify artificial saliva and a host of other devices. The FDA panelists will be taking a good look at root canal cleanser, retraction cords that are used to pull the gums away from the teeth to take accurate dental impressions, root apex locators that measure root canals through electric probes, acrylic mouthguards that protect against tooth grinding and jaw clenching, oral wound dressing and electrical anesthesia.

Dentsply International Inc. (down $0.38 to $51.94, Research) and Sybron Dental Specialties (down $0.24 to $41.26, Research) are the dominant publicly-traded players in the manufacture of dental products, analysts said. Consumable dental products, a category that includes a wide range of dental supplies, make up a $11 billion to $12 billion industry worldwide, with $4.5 billion just in the U.S., according to Lehman Brothers analyst Steven Postal.

"Our view of the [consumable dental products] industry is that it's very stable with very consistent growth," said Postal. "It's depression-resistant. Dentistry is a very lucrative profession right now."

The panelists will vote on how to classify these products and their results will be considered by the FDA at a later date, when the final decisions are made.

Currently, manufacturers must get their products approved by the FDA through a process that is much less stringent than the agency's drug review. Postal said the panel vote is unlikely to have much impact on Dentsply and Sybron, because they offer a myriad of products.

Sybron, which reported $165 million in third-quarter sales, has seen its stock price jump by more than one-third over the last 12 months. The company has prospered because of its rapidly-growing orthodontics business, said Postal, who rates the company "overweight," or buy.

Dentsply, which had $444 million in sales in the second quarter of 2005, has experienced wild volatility in stock price over the last 12 months. Postal rates Dentsply an "equal," or neutral, because 20 percent of its sales come from Germany, which is suffering from high unemployment and a stagnant economy.

In the effort to bring up slumping sales, Dentsply is highlighting its needle-free dental anesthesia Oraqix with the tag line, "Don't get stuck without it!"

Postal does not own stock in the companies mentioned here, though Lehman Brothers has done some business with Sybron in the last 12 months.

To read about the FDA and unusual medical devices, like maggots and leeches, click here.  Top of page

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