Manufacturer registered with FDA
Stengelin Medical
TUTTLINGEN, Germany. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 630 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name Stengelin Medical 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 | Stengelin Medical | 9 device types | — | Below |
| South Korea | MFDS | Manufacturer | Stengelin Medical GmbHSTENGELIN MEDICAL GmbH | 19 | 2011–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Stengelin Medical GmbH | 5 | 2012–2012 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | STENGELIN MEDICAL GMBH | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | STENGELIN MEDICAL GMBH | 2 | 2009–2017 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Stengelin Medical GmbH | 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 Stengelin Medical currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | — | 2013 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 1984 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | — | 2012 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | — | 1984 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | — | 1984 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | — | 2013 |
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 |
|---|---|---|
| Stengelin Medical GmbHFDA reg. 9611278 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010373). 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.