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 Osseotite Dental Implants.

Pre-market Notification Details

Device IDK983347
510k NumberK983347
Device Name:OSSEOTITE DENTAL IMPLANTS
ClassificationImplant, Endosseous, Root-form
Applicant IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
ContactWilliam G Conety
CorrespondentWilliam G Conety
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 Received1998-09-23
Decision Date1999-01-06
Summary:summary

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