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510(k) Data Aggregation
K Number
K050635Device Name
ALLFIM IMPLANT SYSTEMS
Manufacturer
COWELL MEDI CO LTD.
Date Cleared
2005-07-28
(119 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
Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients.
Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options.
The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.
The non-hexa-shoulder abutment is designed for single crown use only. The hexa-shoulder abutment is designed for bridge use only
Device Description
Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous which dostyled in the more and Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options. The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.
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K Number
K041655Device Name
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
Manufacturer
COWELL MEDI CO LTD.
Date Cleared
2004-09-08
(82 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
BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a firm and direct connection between the living bone and surface of the titanium implant. BioPlant implants are for single or two-stage surgical procedures. Bio Plant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type I or II bone), in support of single or multiple-unit restorations including; cemented retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework. Multiple tooth applications may be splinted with a bar.
Device Description
The Bio Plant System includes a variety of types and sizes of precision-machined self-tapping root-form implants, abutments and accessory fixtures manufactured from biocompatible, commercially pure (CP) titanium or biocompatible, wrought titanium or gold alloy. The implants are available with hex-lock features and either smooth (bright) or textured (abrasive blasted) surface finish. Implants range in diameter from 3.3 mm to 6.0 mm and in length from 7 mm to 18 mm. The implants are intended to be surgically inserted into the upper and/or lower jawbone and serve as a substitute or replacement tooth while providing a stable and secure foundation for restorations. Drill sequences, arms and insertion instruments, as specified, are available.
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