Search Results
Found 1 results
510(k) Data Aggregation
K Number
K071148Device Name
ATLAS IMPLANT SYSTEM
Manufacturer
COWELL MEDI CO., LTD.
Date Cleared
2008-02-06
(288 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
COWELL MEDI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.
Device Description
The Atlas Implant System includes a variety of precision-machined fixtures manufactured from titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement for a patient's tooth root providing a stable foundation for restorations.
Ask a Question
Page 1 of 1