510(k) K070663

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

K070663 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT". The FDA issued a decision of Substantially Equivalent on July 5, 2007. 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.