510(k) K082716

A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 by A-Dec, Inc. — Product Code EFB

K082716 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43". The FDA issued a decision of Substantially Equivalent on January 15, 2009. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. A-Dec, Inc. has at least 10 other 510(k) clearances on record.