Manufacturer registered with FDA
Scheu-Dental GmbH
Iserlohn, Germany. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 321 registrations outside the US
- Establishments
- 1Germany
Registered in 3 markets
Where regulators' registries name Scheu-Dental 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 | Scheu-Dental GmbH | 4 device types | — | Below |
| Taiwan | TFDA | Manufacturer | SCHEU-DENTAL GMBH | 15 | 2006–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SCHEU-DENTAL GMBH | 6 | 2020–2025 | 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 Scheu-Dental 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | HerbstIST ApplianceOrthodontic RetainerTelescopesVECTOR Screw | 2002 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | CHROMIUM WireMENZANIUM Wire | 2002 |
| Preformed ClaspEHP · Class 1 | — | Maker | Clasps preformed, Ball clasps, arrow clasps, J clasps, Voss clasps | 2002 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | BIOCRYL CBIOPLAST, BIOPLAST XTREMECOPYPLAST, COPYPLAST CDURAN, DURAN+DURASOFTDURASOFT, DURASOFT pdDURASPLINT LCHARDCASTIMPRELON, IMPRELON S pd, IMPRELON S+ pdUNIQ, UNIQ+ | 2009 |
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 |
|---|---|---|
| SCHEU-DENTAL GMBHFDA reg. 8010874 | ISERLOHN North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010874). 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.