510(k) K963699

BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY by Belmont Equipment Corp. — Product Code EHD

K963699 is an FDA 510(k) premarket notification submitted by Belmont Equipment Corp. for the device "BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Belmont Equipment Corp. has at least 10 other 510(k) clearances on record.