3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS

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 Hydroxylapatite Coated Standard Threaded & Self-tapping Implants.

Pre-market Notification Details

Device IDK955428
510k NumberK955428
Device Name:3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
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 Received1995-11-28
Decision Date1996-02-08

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