ATLANTIS CROWN ABUTMENT, 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 Crown Abutment, Atlantis Gemini +(tm) Abutment.

Pre-market Notification Details

Device IDK110356
510k NumberK110356
Device Name:ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
ClassificationAbutment, Implant, Dental, Endosseous
Applicant ASTRA TECH, INC. 8944 TAMAROA TERR. Skokie,  IL  60076
ContactBetsy A Brown
CorrespondentBetsy A Brown
ASTRA TECH, INC. 8944 TAMAROA TERR. Skokie,  IL  60076
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-07
Decision Date2011-06-10
Summary:summary

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