BRANEMARK SYSTEM DRILLS AND COUNTERSINKS

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 Drills And Countersinks.

Pre-market Notification Details

Device IDK925770
510k NumberK925770
Device Name:BRANEMARK SYSTEM DRILLS AND COUNTERSINKS
ClassificationImplant, Endosseous, Root-form
Applicant NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago,  IL  60632
ContactThomas L Parker
CorrespondentThomas L Parker
NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago,  IL  60632
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-16
Decision Date1993-09-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.