OSTEOGRAF/D-700

Bone Grafting Material, Synthetic

DENTSPLY INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Osteograf/d-700.

Pre-market Notification Details

Device IDK072056
510k NumberK072056
Device Name:OSTEOGRAF/D-700
ClassificationBone Grafting Material, Synthetic
Applicant DENTSPLY INTERNATIONAL, INC. 1311 SMILE WAY York,  PA  17404
ContactHelen Lewis
CorrespondentHelen Lewis
DENTSPLY INTERNATIONAL, INC. 1311 SMILE WAY York,  PA  17404
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-26
Decision Date2007-08-06
Summary:summary

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