Manufacturer registered with FDA
Elos Medtech AB
TIMMERSDALA, Sweden. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 35
- 510(k) clearances
- 0as applicant
- Markets registered in
- 413 registrations outside the US
- Establishments
- 1Sweden
Registered in 4 markets
Where regulators' registries name Elos Medtech AB as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Elos Medtech AB | 3 device types | — | Below |
| South Korea | MFDS | Manufacturer | Elos MedtechELOS Medtech Timmersdala AB | 10 | 2018–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ELOS MEDTECHElos Medtech Timmersdala AB | 2 | 2021–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Elos Medtech AB | 1 | — | Pure 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 AB currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Dental Implant OktagonOKTAGON Bone Level ImplantsOKTAGON Bone Level Tapered Implants | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Ball Abutment ReplicaBall WrenchImpl Pick-up 3.5/4 NI LongImpl Pick-up 3.5/4 NI ShortImpl Pick-up 3.5/4 ShortImpl Pick-up 4.5/5 NI LongImpl Pick-up 4.5/5 NI ShortImplant Guide Pin 3 LongImplant Guide Pin 3 ShortImplant Guide Pin 3.5/4 L 22 moreImplant Guide Pin 3.5/4 SImplant Guide Pin 4.5/5 LImplant Guide Pin 4.5/5 SImplant Pick-up 3 LongImplant Pick-up 3 ShortImplant Pick-up 3.5/4 LongImplant Pick-up 4.5/5 LongImplant Pick-up 4.5/5 ShortImplant Replica 3Implant Replica 3.5/4Implant Replica 4.5/5Implant Transfer 3 LongImplant Transfer 3.5/4 LongImplant Transfer 3.5/4 ShortImplant Transfer 4.5/5 LongImplant Transfer 4.5/5 ShortMultibase EV Lab Abutment Pin - 14 mmMultibase EV Lab Abutment Pin - 18 mmMultibase EV Lab Abutment Pin - 22 mmRatchet Wrench20' UniAbutment Replica45' UniAbutment Replica | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ELOS MEDTECH TIMMERSDALA ABFDA reg. 3003847101 | TIMMERSDALA Vastra Gotaland, Sweden | Contract manufacturer |
Other names on FDA records
Elos Medtech Timmersdala AB
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9078344). 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.