FDA Registration
Active
🇳🇱 Netherlands
Twist Drills
Reg #: 3006540014
·
FEI: 3006540014
·
Expires 2025
Products
1
Proprietary Names
206
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NOBEL BIOCARE DISTRIBUTION CENTER BV
- Registration Number
- 3006540014
- FEI Number
- 3006540014
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Popeweg 72
- City
- Venlo Limburg
- Country
- NL
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 |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2003-07-08 |
Proprietary Names
Twist Drills
Drills Tapered Single-Patient Use
Dense Bone Drill Tapered
Screw Taps NobelActive
NobelActive
Manual Slot Screwdriver
NobelReplace
Abutment Release Pin
N1 Implant Replica
Guided Implant Mounts NobelActive
1st Generation Surgical Templates, NobelGuide
Elos Accurate
Manual Torque Wrenche Surgical
Manual Hexagon Screwdriver
Machine Hex Screwdriver
Guided Template Abutments
Abutment Screw Retrieval Reverse Drill
Manual Omnigrip Mini Screwdriver
N1 IOS Replica Insertion Tool
N1 Base Open/Closed Tray Impression Coping
Implant Driver Conical Connection
Laboratory Guide Pin Implant Level
Locator
Guided Anchor Pin Sleeves
Machine N1 Base Screwdriver
Depth Probe
Guided Implant Mounts NobelParallel
NobelPearl
Manual N1 Base Screwdriver
Direction Indicator
N1 Lab Screws
N1 Base Replica
Implant Driver Branemark System
Surgical Fixation Pins
Adapter for Ratchet
OsseoDirector
Bone Mill for N1 Trioval Conical Connection
Intra-oral Position Locator
Rescue Drill Guide External Hex
Mounting Tool
O-Ring Abutment Analog
Adapter for Manual Torque Wrench Surgical
NobelReplace Open Tray Impression Coping
2nd Generation Surgical Templates, NobelGuide
Bone Mill Branemark System
NobelPerfect Impression Coping
Implant Rescue Collar
Guided Pilot Drill Sleeves
Screw Tap Repair Tool N1
Manual Omnigrip Screwdriver
Radiographic Templates
NobelProcera IOS Replica Insertion Tool
Lab Screw Tri-Lobe
Conical Connection Closed Tray Impression Coping
Protection Analog Multi-unit
Implant Analog
Drill Guide Multi-unit Abutment Plus
N1 Position Locator
Branemark System Open Tray Impression Coping
Abutment Retrieval Tools/Instruments Titanium
Manual Torque Wrenche Prosthetic
Trioval Conical Connection Open/Closed Tray Impression Coping
Cover Screw Mill Branemark System
Multi-unit plus Impression Coping
Novum Impression Coping
Implant Driver Trioval Conical Connection
Guided Anchor Pin
Bone Mill Guide for N1
Manual Multi-unit Screwdriver
Implant Retrieval Instrument
Machine Omnigrip Mini Screwdriver
Guided Pilot Drills
OsseoShaper Extension
Twist Step Drills
Rescue Drill Guide Trioval Conical Connection
Protection Analog/Drill Guide
Abutment Screw Remover
Guided Cylinder with Pin for Branemark
Guided Implant Mounts NobelReplace Conical Connection
Machine On1 Screwdriver
Machine Ball Screwdriver
DESS Dental Smart Solutions
Abutment Screw Retrieval Instrument
Machine Multi-unit Screwdriver
Tissue Punches
Implant Replica Branemark System
Abutment Replica Snappy
Spare Parts: O-Ring
Base Replica N1 Base
Lab Screw Multi-Unit Branemark System/ NobelReplace
Drill Stop
Omnigrip Mini Lab Screw
Depth Indicator
Guided Cylinder with Pin for Conical Connection
Implant Replica Trefoil
Implant Driver NobelActive
Guided Drill Guide
Drill Guard
Bone Mill with Guide NobelReplace
Manual Ball Screwdriver
On1 Closed/ Open Tray Impression Coping
Abutment Retrieval Tools/Instruments Zirconia
Surgical Template Pilot Drill, 1G (3rd Party), NobelGuide
Guide Pin Implant Level
On1 Replica
Guided Cylinder with Pin for NobelReplace
Bone Mill with Guide for Branemark System
Dentalpoint
Protection Analog Conical Connection
Position Locator
Try-in Bar
On1 Prosthetic Lab Screw
Surgical Templates Trefoil
Implant Replica NP IOS Model
Combined Open-end Wrench
Handle for Guided Drill Guide
Manual On1 Screwdriver
Guided Implant Mounts Branemark System
Transmucosal Abutment Wrench
Irrigation Needle
Laboratory Guided Pin
Transfer Hex Impression Coping
Overdenture Bar Attachments
Omnigrip Lab Screw CC / Tri-Channel
Trefoil Lab Screws
Forceps Ti
Branemark System Zygoma Surgical Kit
Bone Mill Guide for Branemark System
Conical Connection Open Tray Impression Coping
Lab Screw Implant Level Branemark System/ NobelReplace/ CC
NobelZygoma Twist Drills
Drills Tapered
Trefoil Implant Mounts
Connection to Handpiece
Implant Replica NobelPerfect
Guided Sleeve
Bone Mill with Guide for Conical Connection
Screw Taps Tapered
Guided start drill
Dense Bone Drill Tapered Single-Patient Use
Round bur
Position Locator N1 Base Kit Box
Rescue Drill Guide Conical Connection
Multi-unit Open/ Closed Tray Impression Coping
Guide drills
Implant Driver NobelReplace
Screw Tap Repair
Abutment Replica Multi-unit
Plastic Coping Snappy Abutment
Manual Implant Driver
Drill Guides
Guided Twist Step Drills
NobelParallel Conical Connection Cortical Drills
Trephine Drill
Laboratory Guide Pin Multi-unit
Drill Extension Shaft
All-on-4 Guide
Surgical Template Fully Guided, 1G, NobelGuide
Branemark System Zygoma Twist Drills
Surgical Template Pilot Drill, 2G, NobelGuide
Guided Screw Taps NobelParallel
Position Locator N1 Base
Machine Slot Screwdriver
Handle for Protection Analogs
Machine UniGrip Screwdriver
Handle for Machine Instruments
Apical Drill Temporary Snap Abutment / Coping
Guided Implant Mounts NobelReplace
Guided Pilot Drill N1
Guided Start Drill/Counterbores
Guided Twist Drills
Metal Adapter Implant Bridge
Manual UniGrip Screwdriver
Implant Replica Novum
Implant Replica Conical Connection
Pilot drills
Counterbores Branemark System
Bone Mill Guide for Conical Connection
Protection Analog NobelReplace
Rescue Drill Guide Tri-Lobe
Adapter for Manual Torque Wrench Prosthetic
Surgical Template Pilot Drill, 1G (Nobel Biocare), NobelGuide
Protection Analog Branemark System
Guided Tissue Punches
Duplicate Denture
Implant Replica NobelReplace
Machine Omnigrip Screwdriver
Transfer Abutment for Trefoil
Branemark Zygoma Impression Coping
NobelPearl Dental Implant System, NobelPearl
Multi-unit Abutment Plus Replica
Periotome Set
Multi-unit Aligning Instrument
Guided Screw Taps
Guided Tapered Drills
Drill Kit
Guided Counterbores
Terrats Medical
Screw Taps
Screw Taps NobelReplace/ Branemark System
Guided Dense Bone Drills
Precision drill
Guided Dense Bone Screw Taps
Screw Taps NobelParallel
Screw Taps Tapered Single-Patient Use
Trefoil Drills
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device