510(k) K992048

MODIFICATION OF PROMPT L-POP by Espe Dental AG — Product Code KLE

K992048 is an FDA 510(k) premarket notification submitted by Espe Dental AG for the device "MODIFICATION OF PROMPT L-POP". The FDA issued a decision of Substantially Equivalent on August 16, 1999. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Espe Dental AG has at least 10 other 510(k) clearances on record.