ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL

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 In Zirconia, Atlantis Gemini Abutment For Nobel Replace Implants, Atlantis Gemini + Abutment For Nobel.

Pre-market Notification Details

Device IDK091920
510k NumberK091920
Device Name:ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL
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 Received2009-06-30
Decision Date2009-09-28
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.