510(k) K990667

KLS-MARTIN TEMPORARY CONDYLAR IMPLANT by KLS-Martin L.P. — Product Code NEI

K990667 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS-MARTIN TEMPORARY CONDYLAR IMPLANT". The FDA issued a decision of Substantially Equivalent on July 27, 2001. The device falls under product code NEI (Prosthesis, Condyle, Mandibular, Temporary), a Class II device regulated under 21 CFR 872.4770. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.