ISS O-RING ATTACHMENT

Implant, Endosseous, Root-form

IMPLANT SUPPORT SYSTEMS, INC.

The following data is part of a premarket notification filed by Implant Support Systems, Inc. with the FDA for Iss O-ring Attachment.

Pre-market Notification Details

Device IDK924190
510k NumberK924190
Device Name:ISS O-RING ATTACHMENT
ClassificationImplant, Endosseous, Root-form
Applicant IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine,  CA  92720
ContactBrian Hill
CorrespondentBrian Hill
IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine,  CA  92720
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-20
Decision Date1993-05-27

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