Manufacturer registered with FDA
Frueh Verpackungstechnik AG
Fehraltorf, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Switzerland
Devices listed with FDA
What Frueh Verpackungstechnik AG 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 | CIM 3.3 mm NDContact Implant, healing cap includedElement implant, healing cap includedImplant Endosseous Root-FormSDS 1.2 Dental ImplantSPI ELEMENT | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | CIM 3.3 mm NDSDS 1.2 Dental Implant | 2017 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Craniofacial Plate and Screw SystemNeuro Plate and Screw System | 2017 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Electric Pen Drive System | 2017 |
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 |
|---|---|---|
| FRUEH VERPACKUNGSTECHNIK AGFDA reg. 3010363503 | Fehraltorf Zurich, Switzerland | Contract manufacturer, Contract sterilizer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043460). 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.