FDA Registration
Active
🇺🇸 United States
Solventum US LLC
Reg #: 3032163716
·
FEI: 3032163716
·
Expires 2026
Products
25
Proprietary Names
9
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- Solventum US LLC
- Registration Number
- 3032163716
- FEI Number
- 3032163716
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2111 McGaw Avenue
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183476
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2019-01-04 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2007-11-28 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 1992-06-29 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-12-05 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2011-02-17 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2007-11-27 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2007-11-27 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2007-11-27 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2007-12-06 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-05-26 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2012-02-07 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 1978-08-31 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2001-02-26 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2011-05-25 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2023-05-15 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2024-09-19 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2008-02-25 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2011-03-16 |
| Tube Impression And Matrix | KCQ | Class 1 | Dental | No | 2025-06-26 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2001-08-06 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2003-11-26 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2001-08-06 |
| Material, Impression | ELW | Class 2 | Dental | No | 2007-12-06 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2001-06-12 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2010-07-15 |
Proprietary Names
CROWN
Burs
Transbond Supreme LV Light Cure Adhesive
Transbond Supreme LV Adhesive,
Transbond Supreme Adhesive,
Transbond Supreme Low Viscosity Adh
Unitek Multi-Cure Glass Ionomer Orthodontic Band Cement
Transbond XT
Transbond LR
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)