ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE

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 Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment, Atlantis Gemini + Straumann Bone.

Pre-market Notification Details

Device IDK083871
510k NumberK083871
Device Name:ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE
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 Received2008-12-29
Decision Date2009-04-15
Summary:summary

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