NOBELPHARMA CERAONE ABUTMENT 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 Nobelpharma Ceraone Abutment System.

Pre-market Notification Details

Device IDK910611
510k NumberK910611
Device Name:NOBELPHARMA CERAONE ABUTMENT SYSTEM
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 Received1991-02-12
Decision Date1991-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07332747016109 K910611 000
07332747016093 K910611 000

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