ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + 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 Abutment For Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini + Abutment.

Pre-market Notification Details

Device IDK093780
510k NumberK093780
Device Name:ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + 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 Received2009-12-09
Decision Date2010-04-16
Summary:summary

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