Manufacturer registered with FDA
Berger Surgical Medical Products GmbH
Neuhausen ob Eck, Germany. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 49 registrations outside the US
- Establishments
- 1Germany
Registered in 4 markets
Where regulators' registries name Berger Surgical Medical Products 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 | Berger Surgical Medical Products GmbH | 4 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Berger Surgical Medical Products GmbH | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Berger Surgical Medical Products GmbH | 3 | 2022–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | Berger Surgical Medical Products GmbHBerger Surgical medical products GmbH | 2 | — | 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 Berger Surgical Medical Products 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 | — | 2020 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2020 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | — | 2020 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | — | 2020 |
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 |
|---|---|---|
| Berger Surgical Medical Products GmbHFDA reg. 3013784566 | Neuhausen ob Eck Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055726). 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.