510(k) K073478

SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS by Sybron Dental Specialties, Inc. — Product Code EFB

K073478 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties, Inc. for the device "SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS". The FDA issued a decision of Substantially Equivalent on September 3, 2008. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Sybron Dental Specialties, Inc. has at least 10 other 510(k) clearances on record.