510(k) K202674

Medidenta High Speed Handpieces by Pac-Dent, Inc. — Product Code EFB

K202674 is an FDA 510(k) premarket notification submitted by Pac-Dent, Inc. for the device "Medidenta High Speed Handpieces". The FDA issued a decision of Substantially Equivalent on December 12, 2022. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Pac-Dent, Inc. has at least 7 other 510(k) clearances on record.