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510(k) Data Aggregation
K Number
K121117Device Name
NDX ABUTMENTS
Manufacturer
Date Cleared
2012-12-14
(246 days)
Product Code
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL DENTEX CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NDX Custom Abutments are 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.
Device Description
NDX Custom Abutments are fabricated for a specific prosthetic case and implant interface using a Computer Assisted Design /Computer Assisted Manufacturing (CAD/CAM) scanning and milling process. Milling of NDX Custom Abutments includes anti-rotation features compatible with specific implant systems. Each abutment is made from titanium alloy. It is created according to the specific design parameters designated by the clinician. All components and parameters of the system remain identical to those cleared for the TDS Abutment System predicates. Abutments are available in diameters of 3.5, 4.1, 4.3, 5.0, 5.1, and 6.0 mm, and can be fabricated straight or with an angle up to 30°.
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