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510(k) Data Aggregation
K Number
K231413Device Name
IPD Dental Implant Abutments
Manufacturer
Date Cleared
2023-10-10
(147 days)
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Implant Protesis Dental 2004 S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
Device Description
IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems. IPD Dental Implant Abutments submission includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant. All subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".
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