Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007689689

FEI Number

3007689689

Entity Name

ELOS MEDTECH PINOL A/S

City/State/Country

Goerloese Hovedstaden, DK

Establishment Address

Engvej 33, Goerloese Hovedstaden DK3330, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Elos Medtech Pinol A/S (Owner Number: 10029200)

Owner / Operator Contact Address

Engvej 33, Goerloese, DK-84 DK3330, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231307

PMA Number

N/A

All Registered Proprietary Names

NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro Screwdriver Provisional Ti Abutment NP NeoLink NP Prepable Ti Abutment NP Abutment Screw NP Elos Accurate® Model Analog Torque wrench kit High Torque Indicating Rachet Wrench Elos Accurate® Scan Body Driver Elos Accurate® Analog Insertion Pin Elos Torque Wrench Kit Elos Accurate® Analog Tool Torque Wrench Elos Accurate® Analog Insertion Screw ADAPTER Elos Driver Elos Accurate® Scan Body Kit Torque Wrench EV Restorative Driver Handle Low Low Torque Indicating Rachet Wrench Torque Wrench EV Torque Wrench EV Restorative Driver Handle Elos Accurate® Analog Pliers TSV Implant Digital Lab analog Placement Tool TSV Implant Digital Lab analog Elos Accurate® Analog for Printed Models Torque Wrench EV Restorative Driver Handle 4x4 Low Nobel Replace, Branemark System, Procera, Nobel Active Torque Wrench EV Surgical Driver Handle Analog for Printed Model Neoss® Elos Accurate® Hybrid Base Non-Engaging Elos Accurate® Hexalobular Prosthetic Screw Elos Accurate® Prosthetic Screwdriver Wrench Adapter Manual Handle Abutment Screw Retrieval Instrument Abutment Retrieval Tools / Instruments Titanium Depth Gauge Implant Inserter Elos Accurate® Scan Body Handle for Machine Instruments LDA SCREW NBR 4.3, 5, 6MM (D) LDA SCREW NBR 3.5MM (D) Handle for Protection Analogs Elos Accurate® Custom Ti Abut Abutment Blank Elos Prosthetic Screw Direction Indicator Abutment Retrieval Tools/Instruments Titanium Manual Torque Wrenche Prosthetic Rescue Drill Guide Trioval Conical Connection Depth Probe Machine Omnigrip Mini Screwdriver Manual Torque Wrenche Surgical OsseoShaper Extension Bone Mill for N1 Trioval Conical Connection Implant Driver Trioval Conical Connection Bone Mill Guide for N1 Cochlear BAHA Implant System Ti Blank Elos Prosthetic Screw Elos Accurate® Custom Ti Abut Abutment Blank NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro Elos Accurate® Custom Ti Abut Elos Prosthetic Screw Abutment Blank NeoLink Ball Abutment, Healing Abutment NobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel Pro CoCr Abutment Crystaloc Abutment Screw TiBase LDA SCREW SBL 3MM(D) LDA SCREW SBL 4MM(D) Provisional Ti Abutment Prepable Ti Abutment Elos Accurate Hybrid Base and Customized Abutment with Prosthetic Screws Torque wrench Nobel Replace, Branemark System Nobel Replace, Nobel Active, Nobel Direct, Branemark System Elos Accurate Pre-milled Blank Elos Accurate® Custom Ti Abut Abutment Blank Elos Prosthetic Screw Elos Accurate Hybrid Base Engaging Elos Accurate Hybrid Base Non-Engaging Elos Accurate® Hybrid Base Engaging Elos Accurate® Hexalobular Prosthetic Screw Elos Accurate® Hybrid Base Non-Engaging Universal Base Non-Engaging Elos Accurate Hybrid Base Elos Accurate Customized Abutment

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	2010-12-15
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2010-11-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-06-19
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2009-04-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2010-12-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-09-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-10-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-01-20
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2023-12-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-06-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-03-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-03-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-06-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-12-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-06-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2016-02-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-06-19
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2024-09-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-09-18
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2020-10-15
HXC	Wrench	Orthopedic	Class 1	888.4540	2010-11-27
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2010-12-12
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2022-12-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-12-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-24
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2021-04-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-04-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-03-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-09-05
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2023-09-05
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2024-01-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-04

Official Correspondent

Lise Terkelsen

US Agent Details

JODIE GILMORE Business: ONYX MEDICAL CORPORATION Email: jodie.gilmore@elosmedtech.com Phone: (901) 3236699

Related Public Records

Same Entity

Elos Medtech Pinol A/S

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

View Entity Profile →

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 3007689689. Last updated year: 2026. Please use registration number 3007689689 when referencing this establishment in official correspondence.