Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027971

FEI Number

1000125598

Entity Name

NOBEL BIOCARE USA, LLC

City/State/Country

YORBA LINDA, CA, US

Establishment Address

22715 Savi Ranch Parkway, YORBA LINDA, CA 92887, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Nobel Biocare Services AG (Owner Number: 8030879)

Owner / Operator Contact Address

Balz-Zimmermann-Strasse 7, Kloten, CH-ZH 8302, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NobelReplace Cover Screws 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 Legacy - Abutment NobelPerfect Abutment Screw NobelReplace NobelReplace Conical Connection PMC Implants Conical Connection Cover Screws NobelReplace Conical Connection Implants 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 Healing Abutment NobRpl Esthetic Abutment NobelReplace Healing Screw ReplaceSelect Legacy Healing Abutments On1 Base Conical Connection On1 Clinical/ Prosthetic Screw On1 Healing Cap Healing Abutment N1 Base On1 Temporary Abutment On1 Esthetic Abutment Healing Abutment Conical Connection Esthetic Abutment Conical Connection NobelProcera Abutments Conical Connection Titanium NobelActive Implants Conical Connection Cover Screws Temporary Abutment Conical Connection Clinical Screw CC NobelProcera Abutments Conical Connection Titanium Clinical Screw CC Snappy Abutment Esthetic Abutment Conical Connection NobelActive Implants Universal Base Abutment Conical Connection NobelParallel CC Implants Temporary Snap Abutment Temporary Coping Multi-unit Snappy Abutment NobelReplace Esthetic Abutment Branemark System Snappy Abutments Branemark System Esthetic Abutment NobelReplace Temporary Abutment NobelReplace Healing Cap Multi-unit Titanium NobelActive Implants Healing Cap Multi-unit Multi-Unit Abutment NobelReplace Angulated Screw Channel (ASC) Abutment Full Contour Zirconia (FCZ) Implant Crown Coping Screw Clinical Adapter for Zirconia Abutments Coronal Screw Clinical Screw Omnigrip Zygoma Screw Multi-Unit Abutment Xeal Conical Connection NobelParallel CC TiUltra Implants On1 Base Xeal NobelReplace CC TiUltra Implants NobelActive TiUltra Implants Abutment Screw Multi-Unit Abutment Plus Conical Connection Temporary Coping Multi-unit Legacy - Direct Abutment Procera Abutments NobelReplace Zirconia Procera Abutments Branemark System Zirconia

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-01-16
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2003-07-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-11-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-05-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-05-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-12-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-03-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-01-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-01-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-08-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-08-03
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2020-07-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-07-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-01-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-12-21
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-08-05
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-12-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-10-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2009-08-03
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-12-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-02-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-11-17
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2020-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-11-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-12-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-03-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-12-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2009-08-03

Official Correspondent

Valeria Barbarito

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nobel Biocare Services AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005739655	Nobel Biocare c/o Medicim NV	Mechelen Antwerpen, BE
3005031178	NOBEL BIOCARE PROCERA, LLC	MAHWAH, NJ, US
9611993	NOBEL BIOCARE AB, PRODUKTION	KARLSKOGA Orebro, SE
3006540014	NOBEL BIOCARE DISTRIBUTION CENTER BV	Venlo Limburg, NL
9611992	NOBEL BIOCARE AB	GOTEBORG Vastra Gotaland, SE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027971. Last updated year: 2026. Please use registration number 2027971 when referencing this establishment in official correspondence.