Registered with FDA
LBN Medical ApS
Aalborg, Denmark. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 25 registrations outside the US
- Establishments
- 1Denmark
Registered in 2 markets
Where regulators' registries name LBN Medical ApS as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | LBN Medical ApS | 4 device types | — | Below |
| South Korea | MFDS | Manufacturer | LBN MEDICAL A/S | 5 | 2015–2022 | 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 LBN Medical ApS 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 | Lister | L8-3 freesyle | 2026 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | XW8000 Workstation | 2024 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | L8-3 freesyle | 2026 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Lister | XW8000 Workstation | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
LBN Medical ApS lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: J. Morita USA, Inc. (1), DENTIN Implants Technologies Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Dec 2017 | K171012 | Veraview X800 | J. Morita USA, Inc. | OAS Dental Computed Tomography X-Ray |
| 5 Jul 2012 | K120530 | DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S | DENTIN Implants Technologies Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LBN MEDICAL A/SFDA reg. 3009196578 | Aalborg Nordjylland, Denmark | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055731). 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.