510(k) K232243

EVO 700 series high speed handpiece by Ttbio Corp. — Product Code EFB

K232243 is an FDA 510(k) premarket notification submitted by Ttbio Corp. for the device "EVO 700 series high speed handpiece". The FDA issued a decision of Substantially Equivalent on August 23, 2023. 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.