BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    NOBEL BIOCARE AB

    Reg #: 9611992 · FEI: 3002807692 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    350
    Establishment Types
    1
    Classifications
    15

    Registration Details

    Registration Name
    NOBEL BIOCARE AB
    Registration Number
    9611992
    FEI Number
    3002807692
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Box 5190, SE-402 26, Vastra Hamngatan 1
    City
    GOTEBORG Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K132749

    Owner / Operator

    Firm Name
    Nobel Biocare Services AG
    Operator Number
    8030879
    Address
    Balz-Zimmermann-Strasse 7
    City
    Kloten
    State
    Zurich
    Postal Code
    8302
    Country
    CH
    Correspondent
    Valeria Barbarito

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Dental Abutment Design Software For Dental Laboratory PNP
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Analyzer, Medical Image MYN
    System, Image Processing, Radiological LLZ
    Drill, Bone, Powered DZI
    Teeth, Porcelain ELL
    Accessories, Implant, Dental, Endosseous NDP
    Automated Radiological Image Processing Software QIH
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Attachment, Precision, All EGG
    Prosthesis, Nose, Internal FZE
    Non-Irrigation Endosseous Dental Implant Drill Bits QRQ

    Proprietary Names

    NobelProcera Implant Bar Overdenture Snappy Abutment NobelReplace Esthetic Abutment Branemark System Snappy Abutments Branemark System Esthetic Abutment NobelReplace PureSet Tray Instrument Set PureSet Spare Parts Temporary Abutment Branemark System DTX Studio lab DTX Studio design NobelProcera Abutments Conical Connection Titanium NobelActive Implants Temporary Abutments PEEK Conical Connection Temporary Abutment Conical Connection Conical Connection Cover Screws Healing Abutments PEEK Conical Connection Snappy Abutment Esthetic Abutment Conical Connection Healing Abutment Conical Connection NobelReplace Cover Screws Legacy - Abutment NobelPerfect Abutment Screw NobelReplace Legacy - Direct Abutment Abutment Screw Handpiece S-11, straight 1:1 DTX Studio™ AI SDK DTX Studio™ Clinic Trefoil Implants Procera Implant Bridge Zirconia Titanium Abutment Blank N1™ TCC NobelZygoma 45 Implants Healing Cap Multi-unit Titanium Zygoma Screw Multi-Unit Abutment Zygoma Temporary Abutment NobelReplace IPS CaseDesigner Metal Adapter for Implant Bridge Clinical NobelZygoma TiUltra Implants Multi-unit Abutments Xeal Zygoma NobelZygoma Multi-unit Abutments Xeal Zygoma Screws NobelReplace Conical Connection PMC Implants NobelReplace Conical Connection Implants NobelProcera Implant Bridge Zirconia Clinical Screw Omnigrip (Mini) NobelProcera Esthetic Implant Bridge Zirconia Temporary Prosthetic Screw Screw Multi-Unit Branemark System/ NobelReplace/CC Abutment Screw Branemark System Prosthetic Screw Converter Screw GoldAdapt Branemark System Gold Coping Multi-unit GoldAdapt NobelReplace Procera Abutments NobelReplace Zirconia Procera Abutments Branemark System Zirconia NobelProcera Abutments Tri-Channel Titanium Clinical Screws for Straumann NobelProcera Abutments Branemark System Titanium Temporary Snap Abutment Temporary Coping Multi-unit Universal Base Abutment Conical Connection DTX Studio Implant Angulated Screw Channel (ASC) Abutment Full Contour Zirconia (FCZ) Implant Crown Coping Screw Clinical Adapter for Zirconia Abutments Coronal Screw Clinical Screw Omnigrip Clinical Screw CC GoldAdapt Conical Connection NobelDesign Software Clinical Screws for Astra Tech/ Straumann Bone Level/ Biomet/ Camlog/ Thommen DTX Studio diagnose DTX Studio Clinic Branemark System Cover Screws Nobel Biocare S Series Implants Esthetic Abutment N1™ TCC Esthetic Abutment N1™ Base Zygoma Implant Cover Screws Zygoma Implants NobelProcera Zirconia Crown Multi-Unit Abutment CC Multi-Unit Abutment Plus Conical Connection NobelActive NobelReplace 1st Generation Surgical Templates, NobelGuide Guided Implant Mounts NobelParallel Bone Mill for N1 Trioval Conical Connection Implant Driver Conical Connection Elos Accurate N1 Base Open/Closed Tray Impression Coping Machine Hex Screwdriver Trioval Conical Connection Open/Closed Tray Impression Coping Implant Retrieval Instrument Machine Omnigrip Mini Screwdriver NobelPearl Guided Pilot Drills OsseoShaper Extension Manual Multi-unit Screwdriver Abutment Release Pin Laboratory Guide Pin Implant Level Screw Tap Repair Tool N1 Guided Implant Mounts NobelActive Guided Template Abutments Twist Step Drills Abutment Screw Retrieval Instrument Machine Multi-unit Screwdriver Locator Manual Hexagon Screwdriver N1 Lab Screws Direction Indicator Guided Anchor Pin Manual Slot Screwdriver Radiographic Templates Manual N1 Base Screwdriver Metal Adapter Implant Bridge Guided Cylinder with Pin for Branemark Machine On1 Screwdriver Machine Ball Screwdriver Bone Mill Guide for N1 Machine N1 Base Screwdriver Rescue Drill Guide Trioval Conical Connection Depth Probe Guided Anchor Pin Sleeves Multi-unit plus Impression Coping Rescue Drill Guide Conical Connection Multi-unit Open/ Closed Tray Impression Coping Implant Driver Trioval Conical Connection OsseoDirector Abutment Screw Retrieval Reverse Drill Manual Omnigrip Mini Screwdriver Abutment Retrieval Tools/Instruments Titanium Manual Torque Wrenche Prosthetic Manual Torque Wrenche Surgical NobelReplace Open Tray Impression Coping 2nd Generation Surgical Templates, NobelGuide Bone Mill Branemark System N1 Base Replica Handle for Guided Drill Guide Guided Implant Mounts Branemark System Screw Tap Repair Protection Analog/Drill Guide Drill Guides Abutment Screw Remover Implant Analog Handle for Protection Analogs N1 Position Locator N1 IOS Replica Insertion Tool Branemark System Zygoma Surgical Kit Implant Replica Conical Connection Lab Screw Implant Level Branemark System/ NobelReplace/ CC On1 Replica Guided Cylinder with Pin for NobelReplace Implant Replica NobelPerfect Bone Mill with Guide for Conical Connection Bone Mill with Guide for Branemark System Intra-oral Position Locator Abutment Retrieval Tools/Instruments Zirconia Protection Analog Conical Connection DESS Dental Smart Solutions N1 Implant Replica Implant Driver NobelReplace Abutment Replica Multi-unit Plastic Coping Snappy Abutment Manual Implant Driver Guided Implant Mounts NobelReplace Conical Connection Omnigrip Lab Screw CC / Tri-Channel Implant Replica NobelReplace NobelPerfect Impression Coping Guided Pilot Drill Sleeves Handle for Machine Instruments Apical Drill Temporary Snap Abutment / Coping Guided Pilot Drill N1 Position Locator N1 Base Kit Box Forceps Ti Bone Mill Guide for Branemark System Conical Connection Open Tray Impression Coping Duplicate Denture Multi-unit Aligning Instrument Machine Omnigrip Screwdriver Transfer Abutment for Trefoil Branemark Zygoma Impression Coping Manual Omnigrip Screwdriver Position Locator Cover Screw Mill Branemark System O-Ring Abutment Analog Lab Screw Tri-Lobe Novum Impression Coping Conical Connection Closed Tray Impression Coping Surgical Templates Trefoil All-on-4 Guide Combined Open-end Wrench NobelPearl Dental Implant System, NobelPearl Transmucosal Abutment Wrench Irrigation Needle Protection Analog NobelReplace Laboratory Guided Pin Rescue Drill Guide Tri-Lobe Transfer Hex Impression Coping Bone Mill with Guide NobelReplace Manual Ball Screwdriver Trefoil Lab Screws Drill Guard NobelProcera IOS Replica Insertion Tool Try-in Bar Protection Analog Multi-unit On1 Prosthetic Lab Screw Precision drill On1 Closed/ Open Tray Impression Coping Guided Implant Mounts NobelReplace Surgical Template Pilot Drill, 1G (3rd Party), NobelGuide Guide Pin Implant Level NobelParallel Conical Connection Cortical Drills Periotome Set Guided Dense Bone Screw Taps Trefoil Drills Overdenture Bar Attachments Implant Replica Trefoil Implant Driver NobelActive Guided Drill Guide Twist Drills Drill Stop Tissue Punches Implant Replica Branemark System Guided Cylinder with Pin for Conical Connection Abutment Replica Snappy Guided Tapered Drills Spare Parts: O-Ring Adapter for Manual Torque Wrench Prosthetic Surgical Template Pilot Drill, 1G (Nobel Biocare), NobelGuide Lab Screw Multi-Unit Branemark System/ NobelReplace Protection Analog Branemark System Pilot drills Guided Twist Drills Guided Screw Taps Trefoil Implant Mounts Connection to Handpiece Guided Sleeve Drills Tapered Single-Patient Use Implant Driver Branemark System Mounting Tool Surgical Fixation Pins Adapter for Ratchet Surgical Template Pilot Drill, 2G, NobelGuide Implant Rescue Collar Base Replica N1 Base Position Locator N1 Base Implant Replica NP IOS Model Machine Slot Screwdriver Machine UniGrip Screwdriver Guided Screw Taps NobelParallel Guided start drill Bone Mill Guide for Conical Connection Surgical Template Fully Guided, 1G, NobelGuide Omnigrip Mini Lab Screw Depth Indicator Laboratory Guide Pin Multi-unit Drill Extension Shaft Guided Tissue Punches Dentalpoint Screw Taps NobelReplace/ Branemark System Guided Counterbores Branemark System Zygoma Twist Drills Manual On1 Screwdriver Manual UniGrip Screwdriver Implant Replica Novum Drill Guide Multi-unit Abutment Plus Multi-unit Abutment Plus Replica Branemark System Open Tray Impression Coping Rescue Drill Guide External Hex Adapter for Manual Torque Wrench Surgical Terrats Medical Guided Implant Mounts Conical Connection Bone Mill with Guide for NobelZygoma Screw Taps Tapered Counterbores Branemark System Drills Tapered Screw Taps Tapered Single-Patient Use Guided Start Drill/Counterbores Screw Taps NobelActive Round bur Screw Taps NobelParallel Guide drills Dense Bone Drill Tapered Drill Kit NobelZygoma Twist Drills Guided Twist Step Drills Guided Dense Bone Drills Dense Bone Drill Tapered Single-Patient Use Trephine Drill Screw Taps Healing Abutment NobRpl Healing Screw ReplaceSelect Legacy Healing Abutments DTX Studio™ Assist Prosthetic Screw N1 Base NobelProcera Zirconia Implant Crown N1 Base NobelProcera Zirconia Abutments N1 Base NobelZygoma 0 Implants Multi-Unit Abutment Branemark System Procera Implant Bridge Titanium Healing Cap Multi-unit Multi-Unit Abutment NobelReplace Screw Ceramic Branemark System/ NobelReplace TREFOIL Framework Trefoil Clinical Screw NobelDesign DTX Studio Design DTX Studio Lab On1 Universal Abutment On1 IOS Healing Caps On1 Base Conical Connection On1 Clinical/ Prosthetic Screw On1 Healing Cap Healing Abutment N1 Base On1 Temporary Abutment On1 Esthetic Abutment Spare Parts: Overdenture Bar Attachments Multi-Unit Abutment Xeal Conical Connection NobelParallel CC TiUltra Implants On1 Base Xeal NobelReplace CC TiUltra Implants NobelActive TiUltra Implants NobelProcera Zirconia Bridge Replace Select Tapered PMC Implants Replace Select TC Implants Replace Select Tapered Healing Abutments Bmk Syst Novum Screw NobelSpeedy Implants Branemark System Mk III TiU Implants N1 Base IOS Healing Abutment Temporary Abutment N1 Trioval Conical Connection Nobel Biocare N1 Cover Screws Clinical Screw N1 Base Nobel Biocare N1 TiUltra Implants Clinical Screw Multi-unit Abutment N1 Trioval Conical Connection N1 Base Trioval Conical Connection Healing Abutment N1 Trioval Conical Connection OsseoShaper 2 Universal Abutment N1 Base Clinical Screw N1 Trioval Conical Connection Temporary Abutment N1 Base OsseoShaper 1 Universal Abutment Trioval Conical Connection Multi-Unit Abutment Trioval Conical Connection Branemark System Zygoma TiUnite Implants Healing Abutment Bmk Syst Zygoma NobelParallel CC Implants

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility