Contract manufacturerDENTSPLY LLC (Milford, DE)DelawareDentalGeneral hospitalClass IIClass IUnclassified
DENTSPLY LLC
Contract manufacturer ยท Milford, DE
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2515379 (openFDA record; or search FDA's registration database)
- FEI number
- 2515379
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- DENTSPLY SIRONA INC (FDA owner/operator no. 2511302)
- Registered address
- 38 WEST CLARKE AVENUE, Milford, DE 19963
- Contract listings
- 21 device listings, 14 product codes, first listed Dec 28, 1977
- 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 |
|---|---|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | Class II | Dental | Contract manufacturing | Mar 6, 2008 |
| EBD | Coating, Filling Material, Resin | Class II | Dental | Contract manufacturing | Sep 5, 2019 |
| EBF | Material, Tooth Shade, Resin | Class II | Dental | Contract manufacturing | Jan 17, 2008 |
| EBG | Crown And Bridge, Temporary, Resin | Class II | Dental | Contract manufacturing | Mar 17, 2025 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Class II | Dental | Contract manufacturing | Jan 16, 2008 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Class I | Dental | Contract manufacturing | Dec 29, 2014 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Class I | Dental | Contract manufacturing | Dec 28, 1977 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | Class I | General hospital | Contract manufacturing | May 10, 1996 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | Class II | General hospital | Contract manufacturing | Apr 16, 2008 |
| KJJ | Cleanser, Root Canal | Unclassified | Dental | Contract manufacturing | Jan 28, 2008 |
| KLE | Agent, Tooth Bonding, Resin | Class II | Dental | Contract manufacturing | Sep 5, 2019 |
| LBH | Varnish, Cavity | Class II | Dental | Contract manufacturing | Oct 16, 2012 |
| MED | Sterilant, Medical Devices | Class II | General hospital | Contract manufacturing | Apr 16, 2008 |
| PZY | Additively Manufactured, Preformed, Resin Denture Tooth | Class II | Dental | Contract manufacturing | Oct 19, 2021 |