FDA Registration
Active
🇩🇪 Germany
Solventum Germany GmbH
Reg #: 9611385
·
FEI: 3002806930
·
Expires 2026
Products
27
Proprietary Names
8
Establishment Types
4
Classifications
27
Registration Details
- Registration Name
- Solventum Germany GmbH
- Registration Number
- 9611385
- FEI Number
- 3002806930
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ESPE PLATZ
- City
- SEEFELD Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K173318
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 |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2017-10-31 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2006-06-20 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2008-12-10 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2011-05-25 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2008-12-10 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2012-03-07 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2008-12-10 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2008-07-09 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2001-06-12 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 1978-08-31 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2010-04-28 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2025-02-21 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2008-12-12 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2006-03-01 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2008-02-25 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2011-05-25 |
| Prophy Powder, Airbrush Accessory | PIP | Class 2 | Dental | No | 2014-11-04 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2008-12-10 |
| Composite Resin Warmer | QGO | Class 1 | Dental | No | 2025-04-01 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2001-02-26 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2001-08-06 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2008-12-10 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2000-09-07 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2003-11-26 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2023-05-15 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2001-08-06 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 1978-03-31 |
Proprietary Names
Impregum Penta Soft MB
VPS Tray Adhesive
Burs
CROWN
OPTICLUDE ORTHOPTIC EYE PATCH
OPTICLUDE
3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch
3M(TM) Nexcare(TM) Gentle Removal Eye Patch
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device