3I ASYST ABUTMENT PACKAGE SYSTEM

Implant, Endosseous, Root-form

IMPLANT INNOVATIONS, INC.

The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for 3i Asyst Abutment Package System.

Pre-market Notification Details

Device IDK951553
510k NumberK951553
Device Name:3I ASYST ABUTMENT PACKAGE SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach,  FL  33407
ContactWilliam G Conety
CorrespondentWilliam G Conety
IMPLANT INNOVATIONS, INC. 3071 CONTINENTAL DR. West Palm Beach,  FL  33407
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-04
Decision Date1995-06-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.