510(k) K031106

IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX by Imtec Corp. — Product Code DZE

K031106 is an FDA 510(k) premarket notification submitted by Imtec Corp. for the device "IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX". The FDA issued a decision of Substantially Equivalent on August 12, 2003. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Imtec Corp. has at least 10 other 510(k) clearances on record.