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510(k) Data Aggregation
K Number
K102822Device Name
IMPLANT-ONE SYSTEM
Manufacturer
CUSTOM DENTAL IMPLANTS INC
Date Cleared
2011-01-10
(104 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM DENTAL IMPLANTS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Implant-One™ system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Device Description
The Implant-One™ Dental Implants include endosseous dental implants, cover screws, healing caps, dental implant abutments and abutment screws in a variety of sizes to accommodate differing patient anatomy. Endosseous implants are self-tapping, root-form and threaded. They range from 3.25mm to 5.5mm in diameter with lengths ranging from 8mm to 14mm and have an internal, threaded abutment connection having a Morse style taper. Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. Abutment options include Standard and Restorative in various heights. These are fastened to the implant using an abutment screw.
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