REPLACE SCALLOPED MARGIN IMPLANT SYSTEM

Implant, Endosseous, Root-form

NOBEL BIOCARE UAS INC

The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Replace Scalloped Margin Implant System.

Pre-market Notification Details

Device IDK021584
510k NumberK021584
Device Name:REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
ContactRichard T Ross
CorrespondentRichard T Ross
NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda,  CA  92887
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-14
Decision Date2002-06-05
Summary:summary

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