510(k) K070869

PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 by Dentalez, Inc. — Product Code EFB

K070869 is an FDA 510(k) premarket notification submitted by Dentalez, Inc. for the device "PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422". The FDA issued a decision of Substantially Equivalent on June 15, 2007. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Dentalez, Inc. has at least 6 other 510(k) clearances on record.