Manufacturer registered with FDA
Kline Europe GmbH
Dusseldorf-Benrath, Germany. Lists 2 dental device types with FDA across 4 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12022–2022
- Markets registered in
- 49 registrations outside the US
- Establishments
- 4Egypt, Mexico, Portugal +1
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Kline Europe GmbH 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 | Kline Europe GmbH | 1 clearances | 2022–2022 | Below |
| Israel | AMAR | Manufacturer | K Line Europe GmbH | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | K-LINE EUROPE GMBH | 2 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | K LINE EUROPE GMBH | 1 | 2013–2013 | 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 Kline Europe GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | — | 2022 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | CLEAR XK Clear | 2021 |
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 Kline Europe GmbH as the applicant, including filings under its other names.
Some of these clearances are listed with FDA today by another company: Ortho Dental Lab, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Border Assembly S. de R.L de C.V.FDA reg. 3035484470 | Tijuana B.C. Baja California, Mexico | Contract manufacturer, Manufacturer, Repacker / relabeler |
| K Line EgyptFDA reg. 3044853366 | Cairo, Egypt | Contract manufacturer, Manufacturer |
| K Line FloridaFDA reg. 3044462786 | West Palm Beach, FL, United States | Contract manufacturer, Manufacturer |
| K Line Portugal Unipessoal LtdFDA reg. 3033492726 | Chaves Braga, Portugal | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
Border Assembly S. de R.L de C.V. · K Line Egypt · K Line Portugal Unipessoal Ltd · K Line Florida
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079939). 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.