FDA Registration
Active
🇩🇪 Germany
Solventum Germany GmbH
Reg #: 3035693034
·
FEI: 3035693034
·
Expires 2026
Products
25
Proprietary Names
7
Establishment Types
1
Classifications
25
Registration Details
- Registration Name
- Solventum Germany GmbH
- Registration Number
- 3035693034
- FEI Number
- 3035693034
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ringstrasse 14
- City
- Kist Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K960954
Owner / Operator
- Firm Name
- Solventum US LLC
- Operator Number
- 10091183
- Address
- 12930 IH 10 West
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- JEFFERY J SCHORR
US Agent
- Business Name
- SOLVENTUM US LLC
- Contact Name
- JEFFERY SCHORR
- Address
- 12930 IH 10 West
- City
- San Antonio
- State
- TX
- ZIP
- 78249
- Country
- US
- [email protected]
- Phone
- 210 2556721
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Dental | EMA | Class 2 | Dental | No | 2008-12-10 |
| Material, Impression | ELW | Class 2 | Dental | No | 2008-12-11 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2008-12-10 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2010-04-28 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2006-06-20 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2008-12-10 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1978-08-31 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2008-12-10 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2000-09-07 |
| Prophy Powder, Airbrush Accessory | PIP | Class 2 | Dental | No | 2014-11-04 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2025-02-21 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2003-11-26 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2012-03-07 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2001-08-06 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2008-12-12 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2001-08-06 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2008-12-10 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2012-01-26 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 1978-03-31 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2007-11-28 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2001-06-12 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2011-05-25 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2007-11-28 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2006-03-01 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2001-02-26 |
Proprietary Names
Burs
VPS Tray Adhesive
CROWN
OPTICLUDE ORTHOPTIC EYE PATCH
OPTICLUDE
3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch
3M(TM) Nexcare(TM) Gentle Removal Eye Patch
Establishment Types
Export Device to the United States But Perform No Other Operation on Device