Manufacturer registered with FDA
Hebu Medical GmbH
TUTTLINGEN, Germany. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 104,229 registrations outside the US
- Establishments
- 1Germany
Registered in 10 markets
Where regulators' registries name Hebu Medical 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 | Hebu Medical GmbH | 14 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | HEBU MEDICAL GMBHHEBUmedical GmbH · HEBUMEDICAL GMBH | 4,037 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | HEBU medical GmbHHEBUMEDICAL GMBH · HEBUmedical GmbH · +2 | 76 | 2001–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HEBUMEDICAL GmbHHEBU MEDICAL GmbH | 57 | 2021–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | HEBUmedical GmbH | 13 | 2023–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Hebu Medical GmbH | 12 | 2004–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HEBU MEDICAL GMBHHEBUmedical GmbH | 12 | 2005–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HEBU MEDICAL GMBHHEBUMEDICAL GMBH | 11 | 2011–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | HEBU medical GmbHHEBU MEDICAL GMBH · HEBU medical (GmbH) · +2 | 8 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HEBU MEDICAL GMBHHEBUMEDICAL GMBH | 3 | — | 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 Hebu Medical 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 | AND OTHERSInstruments, Dental HandMATRIX WAXERSPATULA/PACKER | 2005 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Laryngeal mirror, cone socket, magnifying | 2018 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Forceps, Dressing, Dental | 1979 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | Scissors, Surgical Tissue, Dental | 1979 |
| Preformed BarEHO · Class 1 | — | Maker | Bar, Performed | 2011 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | Carver, Wax, Dental | 2013 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Gauge, Depth, Instrument, Dental | 2013 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | Remover, Crown | 2011 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | FORCEPSForceps, Rongeur, Surgical | 2001 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Elevator, Surgical, Dental | 2013 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Trimmer | 2024 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Scaler, Periodontic | 2005 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Plier, Orthodontic | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | 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 |
|---|---|---|
| HEBUMEDICAL GMBHFDA reg. 9611112 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010320). 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.