510(k) K141183

EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES by Ttbio Corp. — Product Code EFB

K141183 is an FDA 510(k) premarket notification submitted by Ttbio Corp. for the device "EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES". The FDA issued a decision of Substantially Equivalent on February 27, 2015. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Ttbio Corp. has at least 5 other 510(k) clearances on record.