ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA

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 In Zirconia For Dentsply Ankylos Implant, Atlantis Later Abutment In Zirconia.

Pre-market Notification Details

Device IDK120338
510k NumberK120338
Device Name:ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
ClassificationAbutment, Implant, Dental, Endosseous
Applicant ASTRA TECH INC. 8944 TAMAROA TERRACE Skokie,  IL  60076
ContactB A Brown
CorrespondentB 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 Received2012-02-03
Decision Date2012-07-05
Summary:summary

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