BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM

Implant, Endosseous, Root-form

NOBELPHARMA USA, INC.

The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Ovoid & U-shaped Bar System.

Pre-market Notification Details

Device IDK952886
510k NumberK952886
Device Name:BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont,  IL  60559
ContactMary Edwards
CorrespondentMary Edwards
NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont,  IL  60559
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-23
Decision Date1995-09-18

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