510(k) K854741

X-RANGE 65 by Alpine Dental Equipment Co. — Product Code EHD

K854741 is an FDA 510(k) premarket notification submitted by Alpine Dental Equipment Co. for the device "X-RANGE 65". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Alpine Dental Equipment Co. has at least 9 other 510(k) clearances on record.