BRANEMARK SYSTEM TITANIUM COVER SCREWS

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 Titanium Cover Screws.

Pre-market Notification Details

Device IDK925771
510k NumberK925771
Device Name:BRANEMARK SYSTEM TITANIUM COVER SCREWS
ClassificationImplant, Endosseous, Root-form
Applicant NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago,  IL  60606
ContactThomas J Muldoon
CorrespondentThomas J Muldoon
NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago,  IL  60606
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-16
Decision Date1993-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747003239 K925771 000
07332747003222 K925771 000
07332747003215 K925771 000

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