ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, 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 Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini + Abutment.

Pre-market Notification Details

Device IDK093483
510k NumberK093483
Device Name:ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + 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 Received2009-11-09
Decision Date2009-12-22
Summary:summary

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