Manufacturer registered with FDA
Hopf Ringleb & Co GmbH & Cie
BERLIN, Germany. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1454 registrations outside the US
- Establishments
- 1Germany
Registered in 14 markets
Where regulators' registries name Hopf Ringleb & Co GmbH & Cie 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 | Hopf Ringleb & Co GmbH & Cie | 5 device types | — | Below |
| Canada | Health Canada | Registration holder | HOPF, RINGLEB & CO. GMBH & CIE | 12 | 2012–2012 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HOPF, RINGLEB & CO. GMBH & CIE. | 10 | 2011–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hopf, Ringleb & Co. GmbH & Cie. | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Hopf, Ringleb & Co. GmbH & Cie. | 4 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | HOPF, RINGLEB & CO. GMBH & CIEHOPF, RINGLEB & CO. GMBH & CIE. · HOPF,RINGLEB & CO. GMBH & CIE | 4 | 2000–2012 | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | HOPF, RINGLEB & CO. GMBH & CIE. | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hopf Ringleb & Co GmbH & Cie | 3 | 2004–2021 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hopf, Ringleb & Co. GmbH & CIE | 3 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HOPF, RINGLEB & CO. GMBH & CIEHOPF, RINGLEB & CO. GMBH & CIE. | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Hopf, Ringleb & Co. GmbH & CieHopf, Ringleb & Co. GmbH & Cie. | 2 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Hopf, Ringleb & Co. GmbH & Cie. | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | HOPF, RINGLEB & CO. GMBH & CIE | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HOPF, RINGLEB & CO GMBH & CIEHOPF, RINGLEB & CO. GMBH & CIE. | 2 | 2005–2024 | 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 Hopf Ringleb & Co GmbH & Cie 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 | DIAMOND INSTRUMENT | 1997 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | HORICO | 1997 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | HORICO | 1998 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | HORICO | 1998 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | HORICO | 1998 |
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 |
|---|---|---|
| HOPF, RINGLEB & CO. GMBH & CIE.FDA reg. 9614987 | BERLIN, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9031768). 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.