STERI-OSS GOLD ATTACHMENT 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 Steri-oss Gold Attachment System.

Pre-market Notification Details

Device IDK963945
510k NumberK963945
Device Name:STERI-OSS GOLD ATTACHMENT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda,  CA  92887
ContactDon Kennard
CorrespondentDon Kennard
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 Received1996-10-02
Decision Date1997-02-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747010534 K963945 000
07332747010381 K963945 000
07332747010350 K963945 000
17332747000013 K963945 000

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