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510(k) Data Aggregation

    K Number
    K251434

    Validate with FDA (Live)

    Device Name
    Healing Abutment System
    Manufacturer
    Osstem Implant Co., Ltd.
    Date Cleared
    2026-03-04

    (300 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    K222778,K211109,K161604,K160670,K073247,K072642,K062051,K062030,K233194
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Healing Abutment System is indicated for temporary connection to a dental implant to support healing of the surrounding soft tissue.

    Device Description

    Healing Abutment is intended for temporary connection to a dental implant to support healing of the surrounding soft tissue prior to prosthetic placement. And Scan Healing Abutment is intended for temporary connection to a dental implant to support healing of the surrounding soft tissue prior to prosthetic placement. The device incorporates design features intended to facilitate intraoral digital scanning.

    The specifications of the proposed device are as follows.

    Device Content

    TS Healing Abutment

    • Description: The Healing Abutment is intended for temporary connection to a dental implant to support healing of the surrounding soft tissue prior to prosthetic placement.
    • Material: Titanium Grade 4 (ASTM F67)
    • Diameter (D) and Height (H):
      • Ø4.3 x H 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0 mm
      • Ø4.8 x H 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 mm
      • Ø5.3 x H 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0 mm
      • Ø6.3 x H 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0 mm
      • Ø7.3 x H 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0 mm
      • Ø8.3 x H 3.0, 4.0, 5.0, 6.0, 7.0 mm
      • Ø9.3 x H 3.0, 4.0, 5.0 mm

    SS Healing Abutment

    • Description: The Healing Abutment is intended for temporary connection to a dental implant to support healing of the surrounding soft tissue prior to prosthetic placement.
    • Material: Titanium Grade 4 (ASTM F67)
    • Diameter (D) and Height (H):
      • Ø5.5 x H 2.0, 3.0, 4.0, 5.5, 7.0 mm
      • Ø6.7 x H 3.0, 4.0, 5.5 mm

    US Healing Abutment

    • Description: The Healing Abutment is intended for temporary connection to a dental implant to support healing of the surrounding soft tissue prior to prosthetic placement.
    • Material: Titanium Grade 4 (ASTM F67)
    • Diameter (D) and Height (H):
      • Ø4.0 x H 4.1, 5.1, 6.6, 8.1 mm
      • Ø4.13 x H 4.1, 6.6, 8.1 mm
      • Ø5.0 x H 3.1, 4.1, 5.1, 6.6, 8.1 mm
      • Ø5.13 x H 4.1, 6.6 mm
      • Ø6.0 x H 3.1, 4.1, 5.1, 6.6, 8.1 mm
      • Ø7.0 x H 3.1, 4.1, 5.1, 6.6 mm

    SS Scan Healing Abutment

    • Description: The Scan Healing Abutment is intended for temporary connection to a dental implant to support healing of the surrounding soft tissue prior to prosthetic placement. The device incorporates design features intended to facilitate intraoral digital scanning.
    • Material: Titanium Grade 4 (ASTM F67)
    • Diameter (D) and Length (L):
      • Ø5.3 x L 4.0, 5.0, 6.0, 7.0 mm
      • Ø6.3 x L 5.35, 6.35, 7.35 mm

    SS Scan Healing Abutment Screw

    • Description: It is used to connect SS Scan Healing Abutment with implant
    • Material: Ti-6Al-4V (ASTM F136)
    • Diameter (D) and Length (L): Ø2.3 x L 6.3, 7.3, 8.3, 9.3 mm

    US Scan Healing Abutment

    • Description: The Scan Healing Abutment is intended for temporary connection to a dental implant to support healing of the surrounding soft tissue prior to prosthetic placement. The device incorporates design features intended to facilitate intraoral digital scanning.
    • Material: Titanium Grade 4 (ASTM F67)
    • Diameter (D) and Length (L):
      • Ø4.3 x L 4.1, 6.1, 8.1 mm
      • Ø5.3 x L 4.1, 6.1, 8.1 mm
      • Ø6.3 x L 4.1, 6.1 mm

    US Scan Healing Abutment Screw

    • Description: It is used to connect US Scan Healing Abutment with implant
    • Material: Ti-6Al-4V (ASTM F136)
    • Diameter (D) and Length (L):
      • Ø2.2 x L 7.0, 9.0, 11.0
      • Ø2.3 x L 7.0, 9.0, 11.0
      • Ø2.45 x L 7.0, 9.0, 11.0
    AI/ML Overview

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