FDA Registration
Active
🇩🇪 Germany
SCHUETZ DENTAL GMBH
Reg #: 8010711
·
FEI: 7300
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- SCHUETZ DENTAL GMBH
- Registration Number
- 8010711
- FEI Number
- 7300
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DIESELSTRASSE 5-6
- City
- ROSBACH Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K100250
Owner / Operator
- Firm Name
- SCHUTZ DENTAL GMBH
- Operator Number
- 8010711
- Address
- DIESELSTRASSE 5-6, --
- City
- ROSBACH, HESSEN
- State
- DE-NOTA
- Postal Code
- DE 61191
- Country
- DE
- Correspondent
- ANKE - BARTEL
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2006-05-19 |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | Class 1 | Dental | No | 2018-09-12 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2020-05-05 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2006-05-19 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2015-02-13 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 1984-09-25 |
Proprietary Names
JMA Optic
Bite Fork Adapter UN
Tizian JMA Optic
Alignment Spoon (Alignment Fork)
Bite Fork UN
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device