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510(k) Data Aggregation
K Number
K131468Device Name
DENRACLE DENTAL ABUTMENT
Manufacturer
Date Cleared
2014-05-06
(350 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
GREEN DENTECH CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Denracle Dental Abutment for Osstem GS Implant is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system: OSSTEM GS Fixture System Ø 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.
Device Description
Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conjunction with specific dental implants utilizing the Dental Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. Denracle Dental Abutment for Osstem GS Implant is compatible with the following implant systems: OSSTEM GS Fixture System 04.0 mm, Ø4,5 and Ø5,0mm.
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