BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    CERAROOT S.L.

    Reg #: 3008808095 · FEI: 3008808095 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    97
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    CERAROOT S.L.
    Registration Number
    3008808095
    FEI Number
    3008808095
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parpers 13
    City
    Les Franqueses del Valles Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K093595

    Owner / Operator

    Firm Name
    CERAROOT S.L.
    Operator Number
    10034855
    Address
    Parpers 13
    City
    Les Franqueses del Valles
    State
    Barcelona
    Postal Code
    08520
    Country
    ES

    US Agent

    Business Name
    CeraRoot USA Inc.
    Contact Name
    Xavier Oliva
    Address
    2800 Neilson Way, Suite 2
    City
    Santa Monica
    State
    CA
    ZIP
    90405
    Country
    US
    Email
    [email protected]
    Phone
    818 4504776

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP
    Crown, Preformed ELZ

    Proprietary Names

    CeraRoot ceramic implant CeraRoot CeraRoot surgical kit CeraRoot zirconium oxide dental implant Transporter 16 long -steel (00516) Fixation Pin drill 1.5 Guided (FIP-150G) Sleeve for fixation pin drill 1.5 (BPL-1) Steel tweezers with ceramic tip (005.500) Sleeve for cylindrical drill 4.25 (BDC-CR) Cylindrical drill 2,00x14 guided (FAB-1687/04) Initial drill long guided (FAB-1706/02) Countersink 11- ceramic (00411) Cylindrical drill 4,20x18 guided (FAB-1688/04) Lab Analogue 16TL (008.162) Cylindrical drill 4,20x10 guided (FAB-1687/17) Twist drill 2.3 mm -ceramic (00202) Cylindrical drill 3,50x16 guided (FAB-1687/15) Impactor for implant 14 -steel/peek (005.214) bur extension -steel (00106) Transporter 16 short -ceramic (00617) Lab Analogue 21 (008.121) CeraRoot Guided Surgery System (02002S) Transporter TL - steel (005.342) Countersink 14- steel (00314) Transporter 11 -steel (00511) Countersink 12 - steel (FAB-1878) Cylindrical drill 2,00x10 guided (FAB-1687/02) Transporter 16 long -steel (00516-S) Bur extension -steel (AIP-3) Lab Analogue 14 (008.114) Twist drill 4.2 mm -ceramic (00205) Countersink 42 - steel (FAB-1877) Cylindrical drill 2,00x8 guided (FAB-1687/01) Transporter 34 -ceramic (00634) Countersink 11 - steel (FAB-1696) Cylindrical drill 4,20x14 guided (FAB-1687/19) Countersink 14 / 34 - steel (FAB-1694) Lab Analogue 34TL (008.342) Cylindrical drill 2,80x14 guided (FAB-1687/09) Lab Analogue 12 (008.112) Countersink 16- steel (00316) Cylindrical drill 3,50x8 guided (FAB-1687/11) Cylindrical drill 2,80x16 guided (FAB-1687/10) Countersink 14- ceramic (00414) Twist drill 3.5 mm -ceramic (00204) Transporter 12 -ceramic (00612) Cylindrical drill 2,00x16 guided (FAB-1687/05) Fixation Pin 1.5 Guided (PIN-1) Transporter 12 -steel (00512) Cylindrical drill 2,80x8 guided (FAB-1687/06) Transporter 16 long -ceramic (00616) Countersink 11- steel (00311) Transporter 16 short -steel (00517-S) Lab Analogue 16 (008.116) Initial bur/ positioner / triangle -steel (00101) Mallet for implant 14 -steel/plastic (005.114) Twist drill 2.8 mm -ceramic (00203) Cylindrical drill 3,50x18 guided (FAB-1688/03) Lab Analogue 34L (008.234) Transporter TL -ceramic (006.342) Countersink 16 - steel (FAB-1697) Cylindrical drill 4,20x12 guided (FAB-1687/18) Countersink 21 - steel (FAB-1695) Countersink 21- ceramic (00421) Lab Analogue 11 (008.111) Cylindrical drill 3,50x14 guided (FAB-1687/14) Lab Analogue 42 (008.142) Transporter 16 short -steel (00517) Twist drill 2.3 mm -steel (00102) Torque Wrench Kit CeraRoot (03001) Cortical drill guided (FAB-1707) Cylindrical drill 2,80x10 guided (FAB-1687/07) Cylindrical drill 2,80x18 guided (FAB-1688/02) Countersink 16- ceramic (00416) Countersink 21- steel (00321) Contra Angle Driver 4x4 (ACE-8) Ceramic Tray (02004) Cylindrical drill 2,00x18 guided (FAB-1688/01) Cylindrical drill 3,50x12 guided (FAB-1687/13) Lab Analogue 34 (008.134) Cylindrical drill 2,80x12 guided (FAB-1687/08) Guided Surgical Tray (02002) Cylindrical drill 3,50x10 guided (FAB-1687/12) Transporter 11 short -ceramic (006.111) Cylindrical drill 4,20x16 guided (FAB-1687/20) Transporter 34 -steel (00534) Initial drill short guided (FAB-1706/01) Twist drill 3.5 mm -steel (00104) Lab Analogue 21TL (008.212) Transporter 21 -ceramic (00621) Surgical Tray (02001) Twist drill 2.8 mm -steel (00103) Twist drill 4.2 mm -steel (00105) Cylindrical drill 2,00x12 guided (FAB-1687/03) Cylindrical drill 4,20x8 guided (FAB-1687/16) Transporter 21 -steel (00521) TempCrown, Healing Rings, CeraRoot

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility