Manufacturer registered with FDA
Prisman GmbH
Lorsch, Germany. Lists 2 dental device types with FDA across 3 registered establishments.
- Device types listed
- 2
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8139 registrations outside the US
- Establishments
- 3Germany, United States
Registered in 8 markets
Where regulators' registries name Prisman 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 | Prisman GmbH | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | PRISMAN GmbH | 90 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | PRISMAN GmbH | 22 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | PRISMAN GmbHPrisman GmbH | 9 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Prisman GmbH | 6 | 2020–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | PRISMAN GmbH | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PRISMAN GMBHPRISMAN GmbH | 4 | 2009–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | PRISMAN GmbH | 2 | 2026–2026 | 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 Prisman 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 |
|---|---|---|---|---|
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Prophypowder FRESHProphypowder FRESH - MintProphypowder PERIO PLUSProphypowder PERIO PLUS - MintProphypowder SOFT PERIOProphypowder SOFT PERIO - MintProphypowder TOPProphypowder TOP - Mint | 2024 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | CEREC OPTI SPRAY | 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 |
|---|---|---|
| AUREL GmbHFDA reg. 3016965564 | Bensheim Hesse, Germany | Foreign exporter |
| PRISMAN GMBHFDA reg. 3027692624 | Lorsch Hesse, Germany | Contract manufacturer |
| Prisman, Inc.FDA reg. 3030895232 | Beaver, PA, United States | Specification developer |
Other names on FDA records
AUREL GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090401). 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.