ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS

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, Atlantis Gemini, Atlantis Gemini+ Abutments For Astra Osseospeed 3.0 Implants.

Pre-market Notification Details

Device IDK081666
510k NumberK081666
Device Name:ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS
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 Received2008-06-13
Decision Date2008-10-07
Summary:summary

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