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510(k) Data Aggregation

    K Number
    K251547
    Device Name
    DESS Dental Smart Solutions
    Manufacturer
    Terrats Medical SL
    Date Cleared
    2025-10-31

    (163 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K191986,K212628,K222288,K240208,K242340,K083324,K111287,K120414,K101732,K042429,K071638,K063286,K192221,K051614,K201334,K072768,K101545,K112795,K210117,K220200,K110955,K172505,K180282,K142260,K102436,K173418,K050705,K050406,K022562,K161604,K173961,K170588
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

    Device Description

    The purpose of this submission is to expand the DESS Dental Smart Solutions for the DESSLoc Attachment system cleared under K170588, K191986, K212628, K222288, K240208, and K242340 and to:

    • include OEM platform compatibilities to the DESSLoc Abutment design that have been previously cleared in other DESS Abutment designs,
    • include new OEM platform compatibility for MIS C1 Dental Implant System,
    • include attachment components (retention inserts and housing) including reprocessing information in labeling.

    The DESSLoc Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) for resilient attachment of prostheses to endosseous dental implants. There have been no changes to the design of the DESSLoc abutments, the design is the same that has been cleared in the above submissions. The abutments are made of titanium alloy and coated with zirconium nitride (ZrN). The nylon retention insert is manufactured from Polynil® (polyamide 6.6) or Vestamid® Care ML GB30 (polyamide 12). The denture housing is made of titanium alloy with a machined surface or anodized surface. The DESSLoc abutment is compatible with OEM implants, as listed below.

    AI/ML Overview

    N/A

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