FDA Registration
Active
🇨🇭 Switzerland
Nobel Biocare Services AG
Reg #: 3008693672
·
FEI: 3008693672
·
Expires 2026
Products
15
Proprietary Names
352
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- Nobel Biocare Services AG
- Registration Number
- 3008693672
- FEI Number
- 3008693672
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Balz Zimmermann-Strasse 7
- City
- Kloten Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K083205
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2009-08-03 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2009-08-03 |
| Teeth, Porcelain | ELL | Class 2 | Dental | No | 2017-01-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2003-07-08 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2020-11-17 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2017-12-06 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-11-28 |
| Analyzer, Medical Image | MYN | Class 2 | Radiology | No | 2025-11-28 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2017-02-16 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-07-10 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2012-11-14 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2022-01-17 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2016-04-12 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2009-09-10 |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2022-01-10 |
Proprietary Names
NobelActive Implants
NobelProcera Abutments Conical Connection Titanium
Clinical Screw CC
Snappy Abutment
Esthetic Abutment Conical Connection
NobelProcera Abutments Tri-Channel Titanium
Clinical Screw Omnigrip
Abutment Screw
Clinical Screws for Straumann
NobelProcera Abutments Branemark System Titanium
NobelSpeedy Implants
Procera Implant Bridge Zirconia
NobelProcera Zirconia Bridge
Metal Adapter for Implant Bridge Clinical
Healing Cap Multi-unit
Multi-Unit Abutment NobelReplace
Temporary Snap Abutment
Temporary Coping Multi-unit
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
Multi-Unit Abutment Xeal Conical Connection
NobelParallel CC TiUltra Implants
On1 Base Xeal
NobelReplace CC TiUltra Implants
NobelActive TiUltra Implants
DTX Studio lab
DTX Studio design
Prosthetic Screw N1 Base
NobelProcera Zirconia Implant Crown N1 Base
NobelProcera Zirconia Abutments N1 Base
On1 Base Conical Connection
On1 Clinical/ Prosthetic Screw
On1 Healing Cap
Healing Abutment N1 Base
On1 Temporary Abutment
On1 Esthetic Abutment
Nobel Biocare S Series Implants
Temporary Abutment Branemark System
Titanium Abutment Blank N1 TCC
Screw Multi-Unit Branemark System/ NobelReplace/CC
Abutment Screw Branemark System
Prosthetic Screw
Converter Screw
NobelDesign
DTX Studio Design
DTX Studio Lab
Healing Abutments Bmk Syst
Healing Abutment NobRpl
Esthetic Abutment NobelReplace
Healing Screw ReplaceSelect
Legacy Healing Abutments
NobelDesign Software
Multi-Unit Abutment Zygoma
Branemark System Zygoma TiUnite Implants
Healing Abutment Bmk Syst Zygoma
Zygoma Implant Cover Screws
Branemark System Cover Screws
NobelProcera Implant Bridge Zirconia
Clinical Screw Omnigrip (Mini)
NobelProcera Esthetic Implant Bridge Zirconia
Temporary Prosthetic Screw
NobelReplace Cover Screws
DTX Studio Assist
NobelParallel CC Implants
Healing Cap Multi-unit Titanium
DTX Studio Implant
Legacy - Direct Abutment
PureSet Tray
PureSet Spare Parts
Instrument Set
Branemark System Mk III TiU Implants
GoldAdapt Branemark System
Gold Coping Multi-unit
GoldAdapt NobelReplace
IPS CaseDesigner
Screw Ceramic Branemark System/ NobelReplace
Temporary Abutments PEEK Conical Connection
Temporary Abutment Conical Connection
Conical Connection Cover Screws
Healing Abutments PEEK Conical Connection
Healing Abutment Conical Connection
Replace Select Tapered PMC Implants
Replace Select TC Implants
Replace Select Tapered
Multi-Unit Abutment Plus Conical Connection
Temporary Abutment NobelReplace
Handpiece S-11, straight 1:1
NobelProcera Zirconia Crown
Zygoma Implants
Procera Implant Bridge Titanium
Clinical Screw Omnigrip for Titanium Restoration
Omnigrip Prosthetic Screw
Angulated Screw Channel (ASC) Abutment
Full Contour Zirconia (FCZ) Implant Crown
Coping Screw
Clinical Adapter for Zirconia Abutments
Coronal Screw
Zygoma Screw
NobelProcera Implant Bar Overdenture
DTX Studio Clinic
DTX Studio Clinic
NobelZygoma TiUltra Implants
Multi-unit Abutments Xeal Zygoma
NobelZygoma Multi-unit Abutments Xeal Zygoma Screws
Procera Abutments NobelReplace Zirconia
Procera Abutments Branemark System Zirconia
GoldAdapt Conical Connection
Multi-Unit Abutment CC
Universal Base Abutment Conical Connection
Legacy - Abutment NobelPerfect
Abutment Screw NobelReplace
Multi-Unit Abutment Branemark System
Trefoil Implants
Snappy Abutment NobelReplace
Esthetic Abutment Branemark System
Snappy Abutments Branemark System
TREFOIL Framework
Trefoil Clinical Screw
Spare Parts: Overdenture Bar Attachments
Novum Screw
Clinical Screws for Astra Tech/ Straumann Bone Level/ Biomet/ Camlog/ Thommen
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
NobelZygoma 45 Implants
NobelZygoma 0 Implants
DTX Studio AI SDK
On1 Universal Abutment
On1 IOS Healing Caps
Esthetic Abutment N1 TCC
Esthetic Abutment N1 Base
NobelReplace Conical Connection PMC Implants
NobelReplace Conical Connection Implants
DTX Studio diagnose
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility