Contract manufacturerSolventum US LLC (Irvine, CA)CaliforniaDentalClass IIClass I
Solventum US LLC
Contract manufacturer · Irvine, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3032163716 (openFDA record; or search FDA's registration database)
- FEI number
- 3032163716
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- Solventum US LLC (FDA owner/operator no. 10091183)
- Registered address
- 2111 McGaw Avenue, Irvine, CA 92614
- Contract listings
- 6 device listings, 5 product codes, first listed Nov 27, 2007
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Class II | Dental | Contract manufacturing | Nov 27, 2007 |
| DYW | Bracket, Plastic, Orthodontic | Class II | Dental | Contract manufacturing | Nov 27, 2007 |
| EBF | Material, Tooth Shade, Resin | Class II | Dental | Contract manufacturing | Nov 28, 2007 |
| EJF | Bracket, Metal, Orthodontic | Class I | Dental | Contract manufacturing | Nov 27, 2007 |
| NJM | Bracket, Ceramic, Orthodontic | Class II | Dental | Contract manufacturing | Feb 7, 2012 |