Dental Device Guide
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Manufacturer registered with FDA

Elos Medtech Pinol A/S

Goerloese, Denmark. Lists 5 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.

FDA owner/operator10029200Contract manufacturerManufacturer8 clearances in five years
Device types listed
5
Brands and models
98
510(k) clearances
142018–2026
Markets registered in
15136 registrations outside the US
Establishments
1Denmark
2018: 12019: 12020: 32021: 12022: 12023: 22024: 22025: 12026: 220102020

510(k) clearances per year, 2007–2026

Registered in 15 markets

Where regulators' registries name Elos Medtech Pinol A/S as the manufacturer or the registration holder of a device.

All markets
United States: 5 device types listedAustralia: 31 registrationsCanada: 27 registrationsSerbia: 21 registrationsSaudi Arabia: 19 registrationsTaiwan: 8 registrationsSouth Korea: 6 registrationsUnited Kingdom: 6 registrationsColombia: 5 registrationsIsrael: 4 registrationsEuropean Union: 3 registrationsBrazil: 2 registrationsCosta Rica: 2 registrationsChina: 1 registrationsHong Kong: 1 registrations
RegisteredHome: DenmarkOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerElos Medtech Pinol A/S14 clearances2018–2026Below
AustraliaTGAManufacturerElos Medtech Pinol A/S312010–2025Pure Global AI
CanadaHealth CanadaRegistration holderELOS MEDTECH PINOL A/S272016–2025Pure Global AI
SerbiaALIMSManufacturerElos Medtech Pinol A/S212023–2026Pure Global AI
Saudi ArabiaSFDAManufacturerElos Medtech Pinol A/S19—Pure Global AI
TaiwanTFDAManufacturerElos Medtech Pinol A/SELOS MEDTECH PINOL A/S82012–2025Pure Global AI
South KoreaMFDSManufacturerElos Medtech Pinol A/S62010–2026Pure Global AI
United KingdomMHRAManufacturerELOS Medtech Pinol A/S6—Pure Global AI
ColombiaINVIMAManufacturerELOS MEDTECH PINOL A/S5—Pure Global AI
IsraelAMARManufacturerElos Medtech Pinol A/S4—Pure Global AI
European UnionEUDAMEDManufacturerElos Medtech Pinol A/S3—Pure Global AI
BrazilANVISAManufacturerELOS MEDTECH PINOL A/S22022–2024Pure Global AI
Costa RicaMinisterio de SaludManufacturerELOS MEDTECH PINOL A/S2—Pure Global AI
ChinaNMPARegistration holder医乐世（丹麦）医疗器械技术有限公司Elos Medtech Pinol A/S1—Pure Global AI
Hong KongMDDManufacturerElos Medtech Pinol A/S12026–2026Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Elos Medtech Pinol A/S currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
Abutment BlankAbutment ScrewAbutment Screw NPAccess AbutmentAccess Prosthetic ScrewAccess Ti NeoLinkCoCr AbutmentCrystalocDenture Fixation SystemElos Accurate Customized Abutment
26 more
Elos Accurate Hybrid BaseElos Accurate Hybrid Base and Customized Abutment with Prosthetic ScrewsElos Accurate Hybrid Base EngagingElos Accurate Hybrid Base GElos Accurate Hybrid Base Non-EngagingElos Accurate Pre-milled BlankElos Accurate® Custom Ti AbutElos Accurate® Hexalobular Prosthetic ScrewElos Accurate® Hybrid Base™ EngagingElos Accurate® Hybrid Base™ Non-EngagingElos Prosthetic ScrewHandle for Machine InstrumentsLDA SCREW NBR 3.5MM (D)LDA SCREW NBR 4.3, 5, 6MM (D)LDA SCREW SBL 3MM(D)LDA SCREW SBL 4MM(D)NeoLink NPNV.C NuventusPrepable Ti AbutmentPrepable Ti Abutment NPProvisional Ti AbutmentProvisional Ti Abutment NPTi BlankTiBaseTitaniumBase EV ASAUniversal Base Non-Engaging
2010
Dental Abutment Design Software for Dental LaboratoryPNP · Class 2Dental design & orthodontic softwareMaker
Elos Accurate Customized AbutmentElos Accurate Hybrid BaseElos Accurate Hybrid Base and Customized Abutment with Prosthetic ScrewsElos Accurate Hybrid Base EngagingElos Accurate Hybrid Base GElos Accurate Hybrid Base Non-EngagingElos Accurate Pre-milled BlankNV.C NuventusTitaniumBase EV ASA
2021
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
Abutment BlankAbutment Retrieval Tools/Instruments TitaniumBone Mill for N1 Trioval Conical ConnectionBone Mill Guide for N1Depth ProbeDirection IndicatorElos Accurate® Custom Ti AbutElos Prosthetic ScrewHandle for Protection AnalogsImplant Driver Trioval Conical Connection
7 more
Machine Omnigrip Mini ScrewdriverManual Torque Wrenche ProstheticManual Torque Wrenche SurgicalNeoLink Ball Abutment, Healing AbutmentNobelReplace CC, Conical Connection, Branemark System, Replace Select, Abutment EsthetiCone, CeraOne, Procera, Nobel ProOsseoShaper ExtensionRescue Drill Guide Trioval Conical Connection
2010
Powered Bone DrillDZI · Class 2Surgical drills & motorsMaker
Nobel Replace, Nobel Active, Nobel Direct, Branemark System
2010
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Abutment Retrieval Tools / Instruments TitaniumAbutment Screw Retrieval InstrumentADAPTERAnalog for Printed Model Neoss®Denture Fixation SystemDepth GaugeElos Accurate® Analog for Printed ModelsElos Accurate® Analog Insertion PinElos Accurate® Analog Insertion ScrewElos Accurate® Analog Pliers
25 more
Elos Accurate® Analog ToolElos Accurate® Hexalobular Prosthetic ScrewElos Accurate® Hybrid Base™ Non-EngagingElos Accurate® Model AnalogElos Accurate® Prosthetic ScrewdriverElos Accurate® Scan BodyElos Accurate® Scan Body DriverElos Accurate® Scan Body KitElos DriverElos Torque Wrench KitHigh Torque Indicating Rachet WrenchImplant InserterLow Torque Indicating Rachet WrenchManual HandleNobel Replace, Branemark System, Procera, Nobel ActiveTorque WrenchTorque Wrench EVTorque Wrench EV Restorative Driver HandleTorque Wrench EV Restorative Driver Handle 4x4 LowTorque Wrench EV Restorative Driver Handle LowTorque Wrench EV Surgical Driver HandleTorque wrench kitTSV Implant Digital Lab analogTSV Implant Digital Lab analog Placement ToolWrench Adapter
2009

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Elos Medtech Pinol A/S as the applicant.

Decided510(k)DeviceDevice type
30 Sep 2026K261327Elos Accurate Hybrid BaseNHA Endosseous Dental Implant Abutment
20 May 2026K253774Elos Accurate® Denture Fixation SystemNHA Endosseous Dental Implant Abutment
16 Oct 2025K251497Elos Accurate Hybrid BaseNHA Endosseous Dental Implant Abutment
10 Dec 2024K242025Elos Accurate® Hybrid Base™NHA Endosseous Dental Implant Abutment
13 Sep 2024K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentNHA Endosseous Dental Implant Abutment
21 Dec 2023K231307Elos Accurate Customized AbutmentNHA Endosseous Dental Implant Abutment
1 Sep 2023K230317Elos Accurate Hybrid BaseNHA Endosseous Dental Implant Abutment
30 Nov 2022K222044Elos Accurate Customized AbutmentNHA Endosseous Dental Implant Abutment
19 Feb 2021K201860Elos Accurate Hybrid BaseNHA Endosseous Dental Implant Abutment
10 Feb 2020K191919Elos Accurate Hybrid BaseNHA Endosseous Dental Implant Abutment
6 Feb 2020K191890Elos Accurate Customized AbutmentNHA Endosseous Dental Implant Abutment
2 Jan 2020K192457Elos Accurate Customized AbutmentNHA Endosseous Dental Implant Abutment
26 Jun 2019K190299Elos Accurate® Customized AbutmentNHA Endosseous Dental Implant Abutment
15 Jan 2018K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewNHA Endosseous Dental Implant Abutment

Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (6), Dentsply Sirona, Inc. (1).

Registered establishments

EstablishmentLocationWhat it does
ELOS MEDTECH PINOL A/SFDA reg. 3007689689Goerloese Hovedstaden, DenmarkContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10029200). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.