ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...

Abutment, Implant, Dental, Endosseous

ASTRA TECH INC.

The following data is part of a premarket notification filed by Astra Tech Inc. with the FDA for Atlantis(tm) Abutment And Atlantis(tm) Crown Abutment For Keystone Genesis Implant, Atlantis Gemini(tm) Abutment....

Pre-market Notification Details

Device IDK113003
510k NumberK113003
Device Name:ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
ClassificationAbutment, Implant, Dental, Endosseous
Applicant ASTRA TECH INC. 8944 TAMAROA TERRACE Skokie,  IL  60076
ContactBetsy A Brown
CorrespondentBetsy A Brown
ASTRA TECH INC. 8944 TAMAROA TERRACE Skokie,  IL  60076
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-07
Decision Date2012-03-01
Summary:summary

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