Data / Medical devices / Denmark / Elos Medtech Pinol A/S
Elos Medtech Pinol A/S: FDA-registered device maker in Goerloese Hovedstaden, Denmark, 14 510(k) clearances
Elos Medtech Pinol A/S is registered with the FDA (registration 3007689689) in Goerloese Hovedstaden, Denmark. It lists 9 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 30, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3007689689
- Address
- Engvej 33, Goerloese Hovedstaden, Denmark, DK3330
- Owner or operator
- Elos Medtech Pinol A/S (10029200)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 16, 2009
- Registered through
- 2027
- Brand names listed
- ADAPTER, Abutment Blank, Abutment Retrieval Tools / Instruments Titanium, Abutment Retrieval Tools/Instruments Titanium, Abutment Screw, Abutment Screw NP, Abutment Screw Retrieval Instrument, Access Abutment and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Contract manufacturer | accessdata.fda.gov |
| Hearing Aid, Bone Conduction | LXB | 2 | Contract manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 30, 2026 | K261327 | Elos Accurate Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| May 20, 2026 | K253774 | Elos Accurate® Denture Fixation System | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| October 16, 2025 | K251497 | Elos Accurate Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| December 10, 2024 | K242025 | Elos Accurate® Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| September 13, 2024 | K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| December 21, 2023 | K231307 | Elos Accurate Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| September 1, 2023 | K230317 | Elos Accurate Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| November 30, 2022 | K222044 | Elos Accurate Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| February 19, 2021 | K201860 | Elos Accurate Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| February 10, 2020 | K191919 | Elos Accurate Hybrid Base | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| February 6, 2020 | K191890 | Elos Accurate Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| January 2, 2020 | K192457 | Elos Accurate Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| June 26, 2019 | K190299 | Elos Accurate® Customized Abutment | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
| January 15, 2018 | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | NHA | Substantially Equivalent | Elos Medtech Pinol A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Dental Abutment Design Software For Dental Laboratory
- All makers of Implant, Endosseous, Root-Form
- All makers of Drill, Bone, Powered
- All makers of Instrument, Ent Manual Surgical
- All makers of Wrench
Updated September 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.