Nov 17, 2009

Doctors: Powder FAQs

How small are the particles?
The particle size averages 20 microns.

Is it safe?
The powder has undergone a thorough evaluation of its biocompatibility per accepted international and US FDA guidance and the conclusion is that the product is safe for its intended use. Information for safe handling can be found on the product MSDS which is included with the initial purchase or is available from the 3M website (www.mmm.com).

What approvals has the powder received?
The FDA has cleared the 510k for the powder as a class II medical device. The 510K letter is for the Lava C.O.S. system including powder and sprayer.

What is it made of?
The powder is predominantly titanium dioxide, a white material which is used in food coloring and in toothpaste.