BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Inclusive Tapered Implant 30 Multi-Unit Abut. 3.5 mmP x 3 mmH

    Reg #: 2022435 · FEI: 2022435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    173
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2022435
    FEI Number
    2022435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1401 Morgan Cir
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121688

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Inclusive Tapered Implant 30 Multi-Unit Abut. 3.5 mmP x 3 mmH 30 Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level RC 17 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 4.3 mm Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 3.8 mm 30 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 4 mmH compatible with: Branemark System RP Inclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 1 mmH 17 Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 3.4 mm 30 Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 4.3 mm 17 Multi-Unit Abut. 2.5 mmH compatible with: NobelActive NP 17 Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Standard Inclusive Tapered Implant Multi-Unit Abut. 3 mmP x 3.5 mmH Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 1.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System 30 Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive® Multi-Unit Abutment, 4.5 Platform x 3 mmH Inclusive Tapered Implant 17 Multi-Unit Abut. 4.5 mmP x 2 mmH Inclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 3 mmH 30 Multi-Unit Abut. 4.5 mmH compatible with: Astra Tech Implant System 3.5/4 Inclusive® 17 Multi-Unit Abutment, 3.5 Platform x 3 mmH Multi-Unit Abut. 1.5 mmH compatible with: Straumann Bone Level RC Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 5 mmH compatible with: Branemark System RP Inclusive Tapered Implant Multi-Unit Abut. 3 mmP x 2.5 mmH 17 Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Standard Inclusive Tapered Implant 17 Multi-Unit Abut. 3.5 mmP x 3 mmH Multi-Unit Abut. 3 mmH compatible with: MegaGen AnyRidge Implant System 17 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 2 mmH 17 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 5 mm 17 Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Mini Inclusive® 17 Multi-Unit Abutment, 4.5 Platform x 3 mmH Inclusive Tapered Implant 17 Multi-Unit Abut. 3.5 mmP x 2 mmH 17 Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level RC 30 Multi-Unit Abut. 4.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Standard Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 3.5/4 Inclusive® Multi-Unit Abutment, 4.5 Platform x 2 mmH Inclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 3 mmH 17 Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level NC Multi-Unit Abut. 1.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 2 mmH compatible with: NobelReplace RP 17 Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 4.3 mm 17 Multi-Unit Abut. 4 mmH compatible with: NobelReplace RP Multi-Unit Abut. 4.5 mmH compatible with: Hiossen HG System Standard Multi-Unit Abut. 4.5 mmH compatible with: Astra Tech Implant System 4.5/5 Inclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 1 mmH 30 Multi-Unit Abut. 4.5 mmH compatible with: NobelActive RP Multi-Unit Abut. 3 mmH compatible with: NobelReplace RP Multi-Unit Abut. 1 mmH compatible with: NobelReplace RP 17 Multi-Unit Abut. 3 mmH compatible with: Branemark System RP 17 Multi-Unit Abut. 2 mmH compatible with: NobelReplace NP 30 Multi-Unit Abut. 4.5 mmH compatible with: Hiossen HG System Mini 17 Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 1 mmH compatible with: Branemark System RP Inclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 5 mmH Multi-Unit Abut. 4.5 mmH compatible with: Straumann Bone Level RC Multi-Unit Abut. 2 mmH compatible with: Branemark System RP Multi-Unit Abut. 2 mmH compatible with: NobelReplace WP 17 Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 3.5 mmH compatible with: NobelActive NP 17 Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System 17 Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 3.5/4 Multi-Unit Abut. 1 mmH compatible with: NobelReplace WP Inclusive® 30 Multi-Unit Abutment, 4.5 Platform x 3 mmH 30 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive Tapered Implant 30 Multi-Unit Abut. 4.5 mmP x 3 mmH Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 5 mm 30 Multi-Unit Abut. 4.5 mmH compatible with: Hiossen HG System Standard 30 Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Standard 30 Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Mini 17 Multi-Unit Abut. 2 mmH compatible with: NobelReplace RP Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 3.8 mm 30 Multi-Unit Abut. 6.5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 3.4 mm 30 Multi-Unit Abut. 4 mmH compatible with: NobelReplace RP Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 4.5 mmH compatible with: Ankylos /X 30 Multi-Unit Abut. 5 mmH compatible with: Branemark System RP 30 Multi-Unit Abut. 5 mmH compatible with: NobelReplace RP Inclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 5 mmH 30 Multi-Unit Abut. 5 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 1.5 mmH compatible with: Hiossen HG System Standard 30 Multi-Unit Abut. 4.5 mmH compatible with: Astra Tech Implant System 4.5/5 17 Multi-Unit Abut. 3 mmH compatible with: NobelReplace NP Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Mini Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Standard Multi-Unit Abut. 1.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 3.5/4 17 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive NP Inclusive Tapered Implant 17 Multi-Unit Abut. 4.5 mmP x 3 mmH Inclusive® 30 Multi-Unit Abutment, 3.5 Platform x 3 mmH Multi-Unit Abut. 5 mmH compatible with: NobelReplace RP Inclusive Tapered Implant 17 Multi-Unit Abut. 4.5 mmP x 5 mmH 17 Multi-Unit Abut. 2.5 mmH compatible with: NobelActive RP Multi-Unit Abut. 5 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 3.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 4.3 mm 30 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive NP Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level RC 30 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 4.5/5 Inclusive® Tapered Implant Multi-Unit Abutment 3 mmP x 2.5 mmH 17 Multi-Unit Abut. 3 mmH compatible with: NobelReplace RP Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level NC Inclusive® 17 Multi-Unit Abutment, 4.5 Platform x 2 mmH Inclusive® 30 Multi-Unit Abutment, 4.5 Platform x 5 mmH 30 Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 4 mmH compatible with: MegaGen AnyRidge Implant System 17 Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 4.5/5 Multi-Unit Abut. 3 mmH compatible with: Branemark System RP Multi-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level NC Multi-Unit Abut. 1.5 mmH compatible with: Ankylos /X Multi-Unit Abut. 2.5 mmH compatible with: NobelActive RP Multi-Unit Abut. 1.5 mmH compatible with: Straumann Bone Level NC 17 Multi-Unit Abut. 3.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 5 mm Multi-Unit Abut. 1 mmH compatible with: NobelReplace NP Multi-Unit Abut. 2.5 mmH compatible with: NobelActive NP 30 Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 2 mmH Inclusive® Multi-Unit Abutment, 4.5 Platform x 5 mmH Multi-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 5 mm Inclusive® Tapered Implant Multi-Unit Abutment 3 mmP x 3.5 mmH 30 Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 5 mmH compatible with: Camlog Screw-Line 4.3 mm 30 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 3.5/4 Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level RC Multi-Unit Abut. 3.5 mmH compatible with: Ankylos /X 17 Multi-Unit Abut. 3.5 mmH compatible with: Astra Tech Implant System 3.5/4 17 Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 3.4 mm 30 Multi-Unit Abut. 4 mmH compatible with: Branemark System RP 17 Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level NC Multi-Unit Abut. 1.5 mmH compatible with: Astra Tech Implant System 3.5/4 Multi-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 1.5 mmH compatible with: Hiossen HG System Mini Multi-Unit Abut. 2 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Tapered Implant Multi-Unit Abut. 3 mmP x 1.5 mmH 17 Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 5 mm Multi-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 5 mm Inclusive® Tapered Implant Multi-Unit Abutment 3 mmP x 1.5 mmH Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Mini Multi-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 4.3 mm Inclusive® 17 Multi-Unit Abutment, 3.5 Platform x 2 mmH Inclusive® Multi-Unit Abutment, 4.5 Platform x 1 mmH Multi-Unit Abut. 2 mmH compatible with: NobelReplace NP Multi-Unit Abut. 2.5 mmH compatible with: Ankylos /X 17 Multi-Unit Abut. 3.5 mmH compatible with: Straumann Bone Level RC 17 Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 5 mm 30 Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 3.8 mm Multi-Unit Abut. 3 mmH compatible with: NobelReplace NP Inclusive® Multi-Unit Abutment, 3.5 Platform x 1 mmH Inclusive Tapered Implant 30 Multi-Unit Abut. 4.5 mmP x 5 mmH 30 Multi-Unit Abut. 4 mmH compatible with: Biomet 3i Certain 4.1 mm Multi-Unit Abut. 3 mmH compatible with: NobelReplace WP Multi-Unit Abut. 4.5 mmH compatible with: NobelActive RP 17 Multi-Unit Abut. 2 mmH compatible with: Branemark System RP Inclusive® Multi-Unit Abutment, 3.5 Platform x 2 mmH 17 Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Mini Multi-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 3.4 mm Multi-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 5 mm 17 Multi-Unit Abut. 3 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive® 17 Multi-Unit Abutment, 4.5 Platform x 5 mmH Multi-Unit Abut. 3 mmH compatible with: Camlog Screw-Line 4.3 mm 30 Multi-Unit Abut. 4.5 mmH compatible with: Straumann Bone Level RC Dental Abutments Inclusive Multi-Unit Abutments

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)