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510(k) Data Aggregation
K Number
K101068Device Name
ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS
Manufacturer
Date Cleared
2010-08-23
(129 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
RADIANT EXPRESS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AccuFit™ Abutments and screws are intended to attach to an endosseous dental implant and provide support and retention for a single tooth and multiple teeth restoration in the mandible or maxilla.
AccuFit™ Screws are intended for securing a abutment onto an endosseous dental implant.
The AccuFit" Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:
Table A. Compatible Commercial Implant Manufacturers
| Implant Company | Implant System | Implant Platform Diameter |
|---------------------|------------------------|---------------------------|
| Zimmer Dental | Tapered Screw-vent | 3.5, 4.5, 5.7 mm |
| Nobel-Biocare | NobelReplace Select | 3.5, 4.3, 5.0 mm |
| Biomet 3i | Osseotite Certain | 3.4, 4.1, 5.0 mm |
| Lifecore Biomedical | Renova (internal hex) | 3.5, 4.5 mm |
| | Restore (external hex) | 3.3, 4.1, 5.0 mm |
Device Description
The AccuFit" Dental Abutments and Screws are designed for use with commercially available dental implant systems. The abutments will seat directly on implants and are secured by screws to become sub-structure of prosthesis. These abutments are offered in a straight body with a straight or scalloped prosthetic margin and are made of Titanium alloy Ti6AlV4.
A list of dental implant systems, which the AccuFit™ family of products is compatible with, is shown in tables within this document. The abutments and screws of the compatible systems are listed as the predicates for this filing.
The Accurit™ Abutment System is compatible with the commercial implant manufacturer's (Table A) bone-level implant bodies and has mating diameters, lead-in bevels, internal/external hex sizes, and internal threads. Abutments and screws are designed to be compatible with each of the following implant systems and sizes:
Table A. Compatible Commercial Implant Manufacturers
| Implant Company | Implant System | Implant Platform Diameter |
|-----------------|------------------------|---------------------------|
| Zimmer Dental | Tapered Screw-vent | 3.5, 4.5, 5.7 mm |
| Nobel-Biocare | NobelReplace Select | 3.5, 4.3, 5.0 mm |
| Biomet 3i | Osseotite Certain | 3.4, 4.1, 5.0 mm |
| Lifecore | Renova (internal hex) | 3.5, 4.5 mm |
| Biomedical | Restore (external hex) | 3.3, 4.1, 5.0 mm |
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