510(k) K973402

STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM by Steri-Oss, Inc. — Product Code DZE

K973402 is an FDA 510(k) premarket notification submitted by Steri-Oss, Inc. for the device "STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 1997. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Steri-Oss, Inc. has at least 10 other 510(k) clearances on record.