Nobel Biocare Services AG

FDA Device Registration & Listing · Kloten Zurich, CH · Registration 3008693672

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008693672
FEI Number
3008693672
Entity Name
Nobel Biocare Services AG
City/State/Country
Kloten Zurich, CH
Establishment Address
Balz Zimmermann-Strasse 7, Kloten Zurich CH-8302, CH
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
N
Expiration Date (Year)
2026
510(k) Number
K031719
PMA Number
N/A

All Registered Proprietary Names

NobelActive Implants NobelProcera Abutments Conical Connection Titanium Clinical Screw CC Snappy Abutment Esthetic Abutment Conical Connection NobelActive Implants NobelProcera Abutments Conical Connection Titanium NobelProcera Abutments Tri-Channel Titanium Clinical Screw Omnigrip Abutment Screw NobelProcera Abutments Tri-Channel Titanium 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 NobelSpeedy 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 NobelProcera Esthetic Implant Bridge Zirconia NobelProcera Implant Bridge Zirconia PureSet Tray Instrument Set PureSet Spare Parts Branemark System Mk III TiU Implants GoldAdapt Branemark System Gold Coping Multi-unit GoldAdapt NobelReplace NobelProcera Implant Bridge Zirconia IPS CaseDesigner Screw Ceramic Branemark System/ NobelReplace 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 Replace Select Tapered PMC Implants Replace Select TC Implants Replace Select Tapered Multi-Unit Abutment Plus Conical Connection Temporary Coping Multi-unit Esthetic Abutment Conical Connection Gold Coping Multi-unit Temporary Abutment NobelReplace Handpiece S-11, straight 1:1 NobelProcera Zirconia Crown Temporary Abutment Conical Connection Esthetic Abutment NobelReplace Zygoma Implant Cover Screws 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 Clinical Screw Omnigrip 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 Zygoma Screw Multi-Unit Abutment Zygoma DTX Studio Clinic 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 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 2009-08-03
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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-01-29
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-12-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2010-01-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-08-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2007-11-30
ELL Teeth, Porcelain Dental Class 2 872.3920 2017-01-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-08-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-12-19
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-12-21
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2003-07-08
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 2016-06-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-03-11
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2019-03-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-08-09
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-03-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2026-02-24
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-01-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-05-02
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2023-05-02
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-12-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-12-06
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Dental Class 2 872.3661 2017-12-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-08-04
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2014-12-02
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-06-06
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-08-03
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-08-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-12-04
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2015-01-16
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-11-28
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2025-11-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-01-18
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-10-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-02-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2014-12-19
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2023-07-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-01-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-11-30
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2022-01-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2022-01-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2010-07-06
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-12-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-08-03
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 2012-10-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2017-03-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2011-09-07
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
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2012-11-14
ELL Teeth, Porcelain Dental Class 2 872.3920 2016-06-07
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-08-03
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2009-08-03
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2007-03-30
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-08-03
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2020-09-25
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2014-02-11
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2014-07-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-01-16
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2024-01-16
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-06-03
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2025-09-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-09-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2007-11-30
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-05-09
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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2009-08-03

Official Correspondent

Valeria Barbarito

US Agent Details

John Sharobiem Email: john.sharobiem@envistaco.com Phone: (201) 5297103

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
2027971 NOBEL BIOCARE USA, LLC YORBA LINDA, CA, US
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

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 3008693672. Last updated year: 2026. Please use registration number 3008693672 when referencing this establishment in official correspondence.
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