Manufacturer registered with FDA
LEWA-DENTAL Feinmechanik GMBH & CO. KG
REMCHINGEN, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 612 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name LEWA-DENTAL Feinmechanik GMBH & CO. KG 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 | LEWA-DENTAL Feinmechanik GMBH & CO. KG | 1 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | LEWA-DENTAL FEINMECHANIK GMBH & CO.KG | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | LEWA-DENTAL GmbH&Co.KG | 4 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Lewa-Dental GmbH & Co. KG | 1 | 2014–2014 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | LEWA-DENTAL FEINMECHANIK GMBH & CO. KG | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Lewa-Dental Feinmechanik GmbH & Co. KG | 1 | 2016–2016 | 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 LEWA-DENTAL Feinmechanik GMBH & CO. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Lewa-Dental Expansion Screws | 1995 |
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 |
|---|---|---|
| LEWA-DENTAL GMBH & CO. KGFDA reg. 1000385618 | REMCHINGEN Baden-Wurttemberg, Germany | Foreign exporter, Manufacturer |
Other names on FDA records
LEWA-DENTAL GmbH&Co.KG
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9020841). 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.