510(k) K101485

ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E by Bisco, Inc. — Product Code KLE

K101485 is an FDA 510(k) premarket notification submitted by Bisco, Inc. for the device "ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E". The FDA issued a decision of Substantially Equivalent on August 26, 2010. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Bisco, Inc. has at least 10 other 510(k) clearances on record.