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510(k) Data Aggregation
K Number
K011574Device Name
UNIPLANT DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2001-09-28
(129 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
UNIVERSAL IMPLANT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Device Description
The Uniplant Dental Implant System is composed of a solid titanium alloy root-form implant and a solid conical abutment, with associated instruments. The implant is a screw-type, two-stage design, incorporating a titanium cover screw that seals the internal bore of the implant from the physiologic environment during healing. The implant is available in three diameters (3.4, 4.1 and 5.1 mm) and three implanted lengths (10 mm, 12 mm and 14 mm). The system includes surgical instruments such as drills, insertion modules and try-ins. The system includes a solid conical abutment that is intended to the implant by engaging the threaded shaft of the abutment in the internal threaded bore of the implant. The abutment includes a cylindrical transmucosal portion and a tapered, grooved coronal portion, with an internal hex socket at the coronal end to facilitate attachment to the implant. A prosthesis may be fabricated by means of standard crown and bridge techniques for attachment to the abutment.
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