MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS

Abutment, Implant, Dental, Endosseous

IMPLANT INNOVATIONS, INC.

The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for Modification To 3i Patient-specific Dental Abutments And Overdenture Bars.

Pre-market Notification Details

Device IDK052648
510k NumberK052648
Device Name:MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
ContactJim Banic
CorrespondentJim Banic
IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-26
Decision Date2005-10-20
Summary:summary

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