ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

ZIMMER DENTAL INC.

The following data is part of a premarket notification filed by Zimmer Dental Inc. with the FDA for Zimmer Dental Trabecular Metal Implant System.

Pre-market Notification Details

Device IDK132258
510k NumberK132258
Device Name:ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad,  CA  92008 -7308
ContactJulie L Corman
CorrespondentJulie L Corman
ZIMMER DENTAL INC. 1900 ASTON AVE. Carlsbad,  CA  92008 -7308
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-19
Decision Date2013-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024019027 K132258 000
00889024019010 K132258 000
00889024019003 K132258 000
00889024018990 K132258 000
00889024018891 K132258 000
00889024018884 K132258 000
00889024018877 K132258 000
00889024018860 K132258 000

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