CAM STRUCTSURE BARS

Abutment, Implant, Dental, Endosseous

BIOMET 3I, INC.

The following data is part of a premarket notification filed by Biomet 3i, Inc. with the FDA for Cam Structsure Bars.

Pre-market Notification Details

Device IDK101582
510k NumberK101582
Device Name:CAM STRUCTSURE BARS
ClassificationAbutment, Implant, Dental, Endosseous
Applicant BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens,  FL  33410
ContactJose E Cabrera
CorrespondentJose E Cabrera
BIOMET 3I, 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 Received2010-06-07
Decision Date2010-11-08
Summary:summary

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