OSSEOSPEED PLUS

Implant, Endosseous, Root-form

ASTRA TECH AB

The following data is part of a premarket notification filed by Astra Tech Ab with the FDA for Osseospeed Plus.

Pre-market Notification Details

Device IDK120414
510k NumberK120414
Device Name:OSSEOSPEED PLUS
ClassificationImplant, Endosseous, Root-form
Applicant ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego,  CA  92130
ContactLinda K Schulz
CorrespondentLinda K Schulz
ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-10
Decision Date2012-07-31
Summary:summary

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