REPLACE TITANIUM IMPLANT SYSTEM

Implant, Endosseous, Root-form

STERI-OSS, INC.

The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Replace Titanium Implant System.

Pre-market Notification Details

Device IDK964220
510k NumberK964220
Device Name:REPLACE TITANIUM IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda,  CA  92887
ContactPaul Gasser
CorrespondentPaul Gasser
STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda,  CA  92887
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-22
Decision Date1997-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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