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
Implant, Endosseous, Root-Form DZE
Drill, Bone, Powered DZI
Abutment, Implant, Dental, Endosseous NHA
Dental Abutment Design Software For Dental Laboratory PNP
Teeth, Porcelain ELL
Accessories, Implant, Dental, Endosseous NDP
Attachment, Precision, All EGG

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