Contract manufacturerDentsply Sirona Orthodontics Inc. (Sarasota, FL)FloridaDentalClass IClass II
Dentsply Sirona Orthodontics Inc.
Contract manufacturer ยท Sarasota, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1036212 (openFDA record; or search FDA's registration database)
- FEI number
- 1036212
- 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
- 7290 26th Court East, Sarasota, FL 34243
- Contract listings
- 8 device listings, 8 product codes, first listed Feb 20, 1979
- 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 |
|---|---|---|---|---|---|
| DZC | Wire, Orthodontic | Class I | Dental | Contract manufacturing | Aug 12, 1992 |
| DZN | Instruments, Dental Hand | Class I | Dental | Contract manufacturing | Mar 18, 2002 |
| ECB | Unit, Syringe, Air And/Or Water | Class I | Dental | Contract manufacturing | Mar 16, 2006 |
| EGZ | Holder, Film, X-Ray | Class I | Dental | Contract manufacturing | May 1, 1996 |
| EHA | Aligner, Beam, X-Ray | Class I | Dental | Contract manufacturing | Feb 19, 2008 |
| EHZ | Evacuator, Oral Cavity | Class I | Dental | Contract manufacturing | Feb 20, 1979 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class II | Dental | Contract manufacturing | Feb 28, 2006 |
| QJJ | Indirect Bonding Tray | Class I | Dental | Contract manufacturing | Dec 13, 2022 |