Manufacturer registered with FDA
Dr Hopf GmbH and Co KG
Langenhagen, Germany. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 722 registrations outside the US
- Establishments
- 1Germany
Registered in 7 markets
Where regulators' registries name Dr Hopf GmbH and 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 | Dr Hopf GmbH and Co KG | 5 device types | — | Below |
| South Korea | MFDS | Manufacturer | DR.HOPF GMBH&CO.KGDr. HOPF GmbH & Co. KG · Dr. Hopf GmbH & CO. KG · +2 | 8 | 2003–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DR.HOPF GMBH & CO. KGDR. HOPF GMBH & CO.KG · DR HOPF GMBH & CO. KG | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dr Hopf GmbH and Co KG | 3 | 2004–2023 | Pure Global AI |
| Canada | Health Canada | Registration holder | DR. HOPF GMBH & CO. KG | 3 | 2012–2012 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Dr. Hopf GmbH & Co. KG | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DR. HOPF GMBH & CO. KG | 1 | 2021–2021 | 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 Dr Hopf GmbH and 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 |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | — | 1991 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | SUNSHINE DIAMONDS | 2001 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | — | 2001 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | — | 2001 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 2001 |
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 |
|---|---|---|
| DR. HOPF GMBH & CO. KGFDA reg. 8043621 | LANGENHAGEN Lower Saxony, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9002748). 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.