510(k) K261987

Reusable SmartPeg by Osstell AB — Product Code EKX

K261987 is an FDA 510(k) premarket notification submitted by Osstell AB for the device "Reusable SmartPeg". The FDA issued a decision of Substantially Equivalent on September 8, 2026. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Osstell AB has at least 4 other 510(k) clearances on record.