ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT

Abutment, Implant, Dental, Endosseous

ATLANTIS COMPONENTS, INC.

The following data is part of a premarket notification filed by Atlantis Components, Inc. with the FDA for Atlantis Abutment For Keystone Implant, Atlantis Gemini Abutment.

Pre-market Notification Details

Device IDK103020
510k NumberK103020
Device Name:ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
ClassificationAbutment, Implant, Dental, Endosseous
Applicant ATLANTIS COMPONENTS, INC. 8944 TAMAROA TERRACE Skokie,  IL  60076
ContactBetsy Brown
CorrespondentBetsy Brown
ATLANTIS COMPONENTS, INC. 8944 TAMAROA TERRACE Skokie,  IL  60076
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-12
Decision Date2011-02-03
Summary:summary

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