510(k) K240183

Star E900 Handpiece Series by Dentalez, Inc., Stardental Division — Product Code EGS

K240183 is an FDA 510(k) premarket notification submitted by Dentalez, Inc., Stardental Division for the device "Star E900 Handpiece Series". The FDA issued a decision of Substantially Equivalent on September 19, 2024. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Dentalez, Inc., Stardental Division has at least 1 other 510(k) clearance on record.