Manufacturer registered with FDA
Otto Leibinger GmbH
MUHLHEIM, Germany. Lists 21 dental device types with FDA across 1 registered establishment.
- Device types listed
- 21
- Brands and models
- 46
- 510(k) clearances
- 0as applicant
- Markets registered in
- 10241 registrations outside the US
- Establishments
- 1Germany
Registered in 10 markets
Where regulators' registries name Otto Leibinger 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 | Otto Leibinger GmbH | 21 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Otto Leibinger GmbHOtto-Leibinger GmbH | 95 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Otto Leibinger GmbHOTTO LEIBINGER GmbH | 52 | 2001–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | Otto Leibinger GmbH | 34 | 2018–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Otto Leibinger GmbH | 22 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Otto Leibinger GmbH | 19 | 2023–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OTTO LEIBINGER GMBH | 11 | 2006–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Otto Leibinger GmbH | 6 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | OTTO LEIBINGER GMBH | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Otto Leibinger 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 Otto Leibinger 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Bone ScraperGauze Packer | 2008 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Ligature Tucker | 2026 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | DOUBLE SIDED BAND SETTE | 1998 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | BAND PUSHER | 1998 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Adson TweezersDressing ForcepsMicro TweezersMOSQUITO FORCEPSRoot Splinter ForcepsSuture TweezersTissue PliersTooth ForcepsTooth Tweezers | 1998 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Denta Gum ScissorsMicro Scissors | 2012 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Minnesota RetractorRetractors all types | 2008 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Castroveijo Measuring GaugeMeasuring Gauge | 2008 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | Beebee Crown Scissors | 2012 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Periodontal Probe | 2012 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Mirror Handle | 2023 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Trephine | 2008 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Excavator | 2012 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | Mosquito Forceps | 2023 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Extracting ForcepsRoot Forceps | 2023 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | Bone FileMiller Bone File | 2003 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | DissectorELEVATORLocke ElevatorLuxatorPenfield DissectorRoot ElevatorWoodson Elevator | 2001 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Bone ScraperChiselOsteotome | 2008 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Dental ScalerPERIODONTIC (MULTIPLE BRANDS) | 2001 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | PERIODONTIC (MULTIPLE BRANDS)PeriotomeTunneling Knife | 2002 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic Plier | 2026 |
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 |
|---|---|---|
| OTTO LEIBINGER GMBHFDA reg. 9614986 | MUEHLHEIM Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9032125). 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.