BRANEMARK SYSTEM DEC 600 DRILLING UNIT

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 Branemark System Dec 600 Drilling Unit.

Pre-market Notification Details

Device IDK974123
510k NumberK974123
Device Name:BRANEMARK SYSTEM DEC 600 DRILLING UNIT
ClassificationImplant, Endosseous, Root-form
Applicant NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont,  IL  60559
ContactBetsy A Brown
CorrespondentBetsy A Brown
NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont,  IL  60559
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-03
Decision Date1998-05-26
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.