FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM

Implant, Endosseous, Root-form

ASTRA TECH, INC.

The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Fixature Microthread Osseospeed, A Component Of The Astra Tech Implant System.

Pre-market Notification Details

Device IDK053384
510k NumberK053384
Device Name:FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant ASTRA TECH, INC. 11234 EL CAMINO REAL, STE 200 San Diego,  CA  92130
ContactFloyd G Larson
CorrespondentFloyd G Larson
ASTRA TECH, INC. 11234 EL CAMINO REAL, STE 200 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-05
Decision Date2006-03-24
Summary:summary

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