Manufacturer registered with FDA
Steripac GmbH
Calw-Altburg, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Germany
Devices listed with FDA
What Steripac 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2019 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2019 |
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 |
|---|---|---|
| Eurofins STERIPAC GMBHFDA reg. 3009217531 | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer |
Other names on FDA records
Eurofins STERIPAC GMBH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042503). 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.