RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM

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 Restore Self Tapping Dental Implant System.

Pre-market Notification Details

Device IDK924589
510k NumberK924589
Device Name:RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant IMPLANT SUPPORT SYSTEMS, INC. 4790 IRVINE BLVD. #105-137 Irvine,  CA  92720
ContactLynn Cuperus
CorrespondentLynn Cuperus
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 Received1992-09-10
Decision Date1994-06-22

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