DENTAL IMPLANT

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 Dental Implant.

Pre-market Notification Details

Device IDK992937
510k NumberK992937
Device Name:DENTAL IMPLANT
ClassificationImplant, Endosseous, Root-form
Applicant NOBEL BIOCARE UAS INC 22725 SAVI RANCH PKWY. Yorba Linda,  CA  92887
ContactJeff Hausheer
CorrespondentJeff Hausheer
NOBEL BIOCARE UAS INC 22725 SAVI RANCH PKWY. Yorba Linda,  CA  92887
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-31
Decision Date2000-02-29
Summary:summary

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