ELOS MEDTECH PINOL A/S

Registration Details

Registration Name: ELOS MEDTECH PINOL A/S
Registration Number: 3007689689
FEI Number: 3007689689
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Engvej 33
City: Goerloese Hovedstaden
Country: DK

Regulatory Submissions

510(k) Number: K171799

Owner / Operator

Firm Name: Elos Medtech Pinol A/S
Operator Number: 10029200
Address: Engvej 33
City: Goerloese
State: Hovedstaden
Postal Code: DK3330
Country: DK
Correspondent: Lise Terkelsen

US Agent

Business Name: ONYX MEDICAL CORPORATION
Contact Name: JODIE GILMORE
Address: 1800 North Shelby Oaks Drive
City: Memphis
State: TN
ZIP: 38134
Country: US
Email: [email protected]
Phone: 901 3236699

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Implant, Endosseous, Root-Form	DZE	Class 2	Dental	No	2010-12-15
Screwdriver	HXX	Class 1	Orthopedic	No	2010-11-27
Abutment, Implant, Dental, Endosseous	NHA	Class 2	Dental	No	2023-06-19
Accessories, Implant, Dental, Endosseous	NDP	Class 1	Dental	No	2009-04-16
Hearing Aid, Bone Conduction	LXB	Class 2	Ear, Nose, Throat	No	2023-12-01
Dental Abutment Design Software For Dental Laboratory	PNP	Class 2	Dental	No	2024-09-18
Instrument, Ent Manual Surgical	LRC	Class 1	Ear, Nose, Throat	No	2020-10-15
Wrench	HXC	Class 1	Orthopedic	No	2010-11-27
Drill, Bone, Powered	DZI	Class 2	Dental	No	2010-12-12

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 NeoLink Ball Abutment, Healing Abutment 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 Hybrid Base Engaging Elos Accurate Hybrid Base Non-Engaging Elos Accurate® Hybrid Base Engaging Universal Base Non-Engaging Elos Accurate Hybrid Base Elos Accurate Customized Abutment TitaniumBase EV ASA Access Prosthetic Screw Access Abutment Access Ti NeoLink NV.C Nuventus

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device