3I OSSEOTITE DENTAL 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 Osseotite Dental Implants.

Pre-market Notification Details

Device IDK051461
510k NumberK051461
Device Name:3I OSSEOTITE DENTAL IMPLANTS
ClassificationImplant, Endosseous, Root-form
Applicant IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
ContactJacqueyl A Hughes
CorrespondentJacqueyl A Hughes
IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-03
Decision Date2005-09-15
Summary:summary

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