OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE

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; Osseotite Nt; Xp; Tg Osseotite.

Pre-market Notification Details

Device IDK063286
510k NumberK063286
Device Name:OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE
ClassificationImplant, Endosseous, Root-form
Applicant IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
ContactJacquelyn A Hughes
CorrespondentJacquelyn 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 Received2006-10-31
Decision Date2007-04-24
Summary:summary

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