510(k) K093575

GLUMA DESENSITIZER POWER GEL by Heraeus Kulzer, LLC — Product Code LBH

K093575 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, LLC for the device "GLUMA DESENSITIZER POWER GEL". The FDA issued a decision of Substantially Equivalent on March 5, 2010. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Heraeus Kulzer, LLC has at least 10 other 510(k) clearances on record.