FDA Registration
Active
🇺🇸 United States
NOBEL BIOCARE PROCERA, LLC
Reg #: 3005031178
·
FEI: 3005031178
·
Expires 2026
Products
7
Proprietary Names
247
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- NOBEL BIOCARE PROCERA, LLC
- Registration Number
- 3005031178
- FEI Number
- 3005031178
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 800 Corporate Dr
- City
- MAHWAH
- State
- NJ
- ZIP
- 07430
- Country
- US
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2017-05-19 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2017-05-19 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2017-05-19 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2025-12-04 |
| Teeth, Porcelain | ELL | Class 2 | Dental | No | 2017-01-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2003-07-08 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2009-09-10 |
Proprietary Names
TREFOIL Framework
Trefoil Clinical Screw
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
Prosthetic Screw N1 Base
NobelProcera Zirconia Implant Crown N1 Base
NobelProcera Zirconia Abutments N1 Base
NobelProcera Implant Bridge Zirconia
NobelProcera Implant Bar Overdenture
Procera Implant Bridge Titanium
Clinical Screw CC
Elos Accurate Hybrid Base and Customized Abutment with Prosthetic Screw
NobelProcera Abutments Tri-Channel Titanium
Clinical Screws for Straumann
NobelProcera Abutments Branemark System Titanium
Clinical Screw Omnigrip
Procera Abutments NobelReplace Zirconia
Procera Abutments Branemark System Zirconia
Procera Implant Bridge Zirconia
Metal Adapter for Implant Bridge Clinical
Clinical Screw Omnigrip (Mini)
NobelProcera Esthetic Implant Bridge Zirconia
Temporary 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 Zirconia Bridge
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
NobelProcera Zirconia Crown
Spare Parts: Overdenture Bar Attachments
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198