BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS

Abutment, Implant, Dental, Endosseous

NOBELPHARMA USA, INC.

The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Titanium Healing Abutments.

Pre-market Notification Details

Device IDK925779
510k NumberK925779
Device Name:BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS
ClassificationAbutment, Implant, Dental, Endosseous
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 CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-16
Decision Date1993-04-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747069624 K925779 000
07332747003307 K925779 000
07332747003314 K925779 000
07332747003321 K925779 000
07332747003338 K925779 000
07332747003345 K925779 000
07332747003376 K925779 000
07332747003383 K925779 000
07332747015867 K925779 000
07332747015874 K925779 000
07332747015881 K925779 000
07332747015898 K925779 000
07332747015904 K925779 000
07332747015911 K925779 000
07332747015928 K925779 000
07332747015935 K925779 000
07332747029215 K925779 000
07332747069617 K925779 000
07332747003291 K925779 000

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