510(k) K122582

DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) by Denterprise International, Inc. — Product Code EHD

K122582 is an FDA 510(k) premarket notification submitted by Denterprise International, Inc. for the device "DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)". The FDA issued a decision of Substantially Equivalent on December 7, 2012. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Denterprise International, Inc. has at least 3 other 510(k) clearances on record.