BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BO1050 - Bolero 5 mm in diameter

    Reg #: 3021076825 · FEI: 3021076825 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    83
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ABRACADABRA IMPLANTS LTD.
    Registration Number
    3021076825
    FEI Number
    3021076825
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Haharoshet 12
    City
    Or Yehuda Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K202092

    Owner / Operator

    Firm Name
    Abracadabra Implants Ltd.
    Operator Number
    10083470
    Address
    Haharoshet 12
    City
    Or Yehuda
    State
    Central
    Postal Code
    6037580
    Country
    IL
    Correspondent
    Daniel Younisian

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    BO1050 - Bolero 5 mm in diameter STSA 03 - straight shoulder abutment 4.50mm in diameter SHCW 5 - standard healing cap wide 5.5 mm SHC 6 - standard healing cap 4.6 mm SHC 4 - standard healing cap 4.6 mm STSWA 2 - straight shoulder wide abutment 5.50mm in diameter BO1137 - Bolero 3.75 mm in diameter BO1042 - Bolero 4.2 mm in diameter BO1150 - Bolero 5 mm in diameter SBA 4 - standard ball attachment STAA 15-1 - anatomic angular abutment 15 degrees SHCXW 5 - standard healing cap extra wide 5.5 mm STWA 9 - grooved straight wide abutment 5.5 mm in diameter BO1633 - Bolero 3.3 mm in diameter SBA 3 - standard ball attachment SBA 2 - standard ball attachment SOD 1.5 - standard overdenture BO0837 - Bolero 3.75 mm in diameter SHCN 7 - standard healing cap narrow 3.8 mm SHC 5 - standard healing cap 4.6 mm SSTWA 11 - smooth straight abutment wide SHCXW 2 - standard healing cap extra wide 5.5 mm STSA 02 - straight shoulder abutment 4.50mm in diameter SOD 0.5 - standard overdenture SHCW 6 - standard healing cap wide 5.5 mm STSWA 1 - straight shoulder wide abutment 5.50mm in diameter SSA 083 - standard screw for abutment SBA 5 - standard ball attachment STSA 04 - straight shoulder abutment 4.50mm in diameter BO1060 - Bolero 6 mm in diameter SMU 4 - standard multi unit STAA 15-2 - anatomic angular abutment 15 degrees BO1160 - Bolero 6 mm in diameter SSFMU - standard screw for multi unit abutment BO1337 - Bolero 3.75 mm in diameter BO1133 - Bolero 3.3 mm in diameter SHCW 7 - standard healing cap wide 5.5 mm SHCW 2 - standard healing cap wide 5.5 mm SHCN 6 - standard healing cap narrow 3.8 mm BO1637 - Bolero 3.75 mm in diameter STA 11 - straight abutment 11 mm SOD 2.5 - standard overdenture SCS 375 - standard cover screw BO0860 - Bolero 6 mm in diameter BO1350 - Bolero 5 mm in diameter STNA 7 - standard titanium narrow abutment 7 mm SMU 3 - standard multi unit SMU 1 - standard multi unit STNA 11 - standard titanium narrow abutment 11 mm STA 7 - straight abutment 7 mm SHC 3 - standard healing cap 4.6 mm STAA 25-1 - anatomic angular abutment 25 degrees BO1037 - Bolero 3.75 mm in diameter SHCN 3 - standard healing cap narrow 3.8 mm STAA 25-2 - anatomic angular abutment 25 degrees BO1642 - Bolero 4.2 mm in diameter SHCN 5 - standard healing cap narrow 3.8 mm SHCXW 4 - standard healing cap extra wide 5.5 mm SSTWA 9 - smooth straight abutment wide SMU 2 - standard multi unit SSF - fixation screw SHC 7 - standard healing cap 4.6 mm STNA 9 - standard titanium narrow abutment 9 mm STSA 01 - straight shoulder abutment 4.50mm in diameter BO1342 - Bolero 4.2 mm in diameter SHCN 4 - standard healing cap narrow 3.8 mm SHCW 4 - standard healing cap wide 5.5 mm STSWA 3 - straight shoulder wide abutment 5.50mm in diameter SSTWA 7 - smooth straight abutment wide BO1033 - Bolero 3.3 mm in diameter BO1142 - Bolero 4.2 mm in diameter STAA 25-3 - anatomic angular abutment 25 degrees SHC 2 - standard healing cap 4.6 mm BO0850 - Bolero 5 mm in diameter STAA 15-3 - anatomic angular abutment 15 degrees STA 9 - straight abutment 9 mm BO1333 - Bolero 3.3 mm in diameter SHCW 3 - standard healing cap wide 5.5 mm SBA 6 - standard ball attachment SHCXW 3 - standard healing cap extra wide 5.5 mm BO0833 - Bolero 3.3 mm in diameter BO0842 - Bolero 4.2 mm in diameter BO1360 - Bolero 6 mm in diameter

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility